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A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-690,550 Eye drops
CP-690,550 Eye drops
CP-690,550 Eye drops
CP-690,550 Eye drops-vehicle
Sodium Hyaluronate
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry eye

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjective symptoms of dry eye for at least 6 months
  • Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)

Exclusion Criteria:

  • Women who are nursing, pregnant or planning pregnancy during the study
  • Participation in other studies within 30 days of screening visit
  • Ocular disorders that may confound interpretation of study results

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Treatment 1

Treatment 2

Treatment 3

Treatment 4

Treatment 5

Arm Description

Outcomes

Primary Outcome Measures

Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.

Secondary Outcome Measures

Changes in Corneal Staining Scores for Study Eye From Baseline
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Number of Participants With Ocular Adverse Events (AEs)by Severity
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.

Full Information

First Posted
June 1, 2010
Last Updated
March 27, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01135511
Brief Title
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease
Official Title
A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Title
Treatment 2
Arm Type
Experimental
Arm Title
Treatment 3
Arm Type
Experimental
Arm Title
Treatment 4
Arm Type
Placebo Comparator
Arm Title
Treatment 5
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CP-690,550 Eye drops
Intervention Description
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550 Eye drops
Intervention Description
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550 Eye drops
Intervention Description
Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
Intervention Type
Drug
Intervention Name(s)
CP-690,550 Eye drops-vehicle
Intervention Description
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Intervention Description
Ophthalmic topical solution, dosed 6 times/day, 8 weeks
Primary Outcome Measure Information:
Title
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Description
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Changes in Corneal Staining Scores for Study Eye From Baseline
Description
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2 and 4
Title
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Description
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 1, 2, 4 and 8
Title
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Description
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
Description
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
Description
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
Description
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 1, 2, 4 and 8
Title
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
Description
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 1, 2, 4 and 8
Title
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
Description
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
Description
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Week 1, 2, 4 and 8
Title
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
Description
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
Description
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
Description
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
Description
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time Frame
Baseline, Week 1, 2, 4 and 8
Title
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
Description
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 1, 2, 4 and 8
Title
Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
Description
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 8
Title
Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
Description
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 8
Title
Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
Description
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 8
Title
Number of Participants With Ocular Adverse Events (AEs)by Severity
Description
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame
8 weeks
Title
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Description
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame
8 weeks
Title
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Description
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye
Description
The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye
Description
Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4
Description
Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time Frame
Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8
Title
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein
Description
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time Frame
Baseline, Week 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjective symptoms of dry eye for at least 6 months Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia) Exclusion Criteria: Women who are nursing, pregnant or planning pregnancy during the study Participation in other studies within 30 days of screening visit Ocular disorders that may confound interpretation of study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ichinomiya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Narashino
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Urayasu
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kangawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fuji
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Numazu
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Susono
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hamura
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ohta-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sumida-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tachikawa
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Taito-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kyoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921072&StudyName=A%20Phase%20II%2C%20Dose%20Ranging%20Study%20Of%20CP-690%2C550%20Eye%20Drops%20In%20Patients%20With%20Dry%20Eye%20Disease
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

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