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A Study Of Tasocitinib In Dry Eye Subjects

Primary Purpose

Keratoconjunctivitis Sicca

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tasocitinib
Tasocitinib
vehicle for Tasocitinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring Dry Eye, Schirmer test, corneal staining, OSDI, OCI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females aged 18 years or older at time of consent
  • Diagnosis of dry eye disease, characterized by subjective symptoms of dry eye for at least 6 months, Schirmer test without anesthesia: =>1 mm and =<7 mm, sum of corneal fluorescein staining score of =>4 (NEI Scale), and subject grading total score of => 23 on the OSDI

Exclusion Criteria:

  • Planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of the Screening visit or during study
  • Ocular disorders that may confound interpretation of study results such as significant corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal tear spreading, including but not limited to the following: abnormal lid function, lid position, or blink rate, that in the opinion of the investigator is clinically significant, history of herpetic keratopathy
  • Lacrimal punctal occlusion (plugs or cautery) within 2 months of the Screening visit
  • Contact lens wear within 2 weeks of the Screening visit and/or during study participation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Tasocitinib 0.005% QD

    Tasocitinib 0.003% QD

    Vehicle for Tasocitinib

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in length of wetting of Schirmer test strip without anesthesia from baseline
    Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline

    Secondary Outcome Measures

    Systemic safety: adverse events, clinical laboratory; and vital signs
    Ocular tolerability and safety: incidence and severity of ocular adverse events during the study (ophthalmic examination, ocular tolerability assessment and/ or adverse events spontaneously reported)
    Schirmer test without anesthesia: Change in length of wetting from baseline at Days 7, 14, 28, and Week 8; Response rate (percentage of subjects who achieve ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Response rate (percentage of
    subjects who achieve increase of ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of change from baseline of ≥10mm wetting;Time to achievement of ≥10mm wetting
    Corneal staining:Change from baseline at Days 7, 14, 28 and Weeks 8 and 12;Response rate (percentage of subjects who demonstrate 100% clearing of corneal staining) at Days 7, 14, 28 and Weeks 8 and 12;Time to achievement of 100% clearing of corneal
    staining
    Ocular Surface Disease Index (OSDI): Change in the OSDI total score and three subscale scores (the Ocular Symptoms, Vision-Related Function, and Environmental Triggers) from baseline at Days 7, 14, 28, and Weeks 8 and 12 (except ET subscale
    score); Response rate (percentage of subjects who demonstrating ≥10 unit decrease in OSDI total score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥10 unit decrease in OSDI total score
    Modified Ocular Comfort Index (mOCI): Change in the OCI score, the Dry Eye Symptoms (DES) and Symptom Interference (SI) subscales scores from baseline at Days 7, 14, 28 and Weeks 8 and 12; OCI Response rate (percentage of subjects who demonstrating
    ≥3 point decrease from baseline in the OCI score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥3 point decrease from baseline in the OCI score

    Full Information

    First Posted
    October 20, 2010
    Last Updated
    November 27, 2018
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01226680
    Brief Title
    A Study Of Tasocitinib In Dry Eye Subjects
    Official Title
    A Phase II, Randomized, Double Masked, Parallel Group, Vehicle Controlled, Multiple-Dose Study Of Tasocitinib (CP-690,550) In Subjects With Dry Eye Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 1, 2010 (Actual)
    Primary Completion Date
    October 19, 2012 (Anticipated)
    Study Completion Date
    October 19, 2012 (Anticipated)

    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
    This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib (CP-690,550) in the subjects with moderate to severe dry eye disease. Both subjective and objective clinical endpoints will be measured for a duration of 12-week treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconjunctivitis Sicca
    Keywords
    Dry Eye, Schirmer test, corneal staining, OSDI, OCI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tasocitinib 0.005% QD
    Arm Type
    Experimental
    Arm Title
    Tasocitinib 0.003% QD
    Arm Type
    Experimental
    Arm Title
    Vehicle for Tasocitinib
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Tasocitinib
    Intervention Description
    0.005% QD for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Tasocitinib
    Intervention Description
    0.003% QD for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    vehicle for Tasocitinib
    Intervention Description
    vehicle QD for 12 weeks
    Primary Outcome Measure Information:
    Title
    Change in length of wetting of Schirmer test strip without anesthesia from baseline
    Time Frame
    Week 12
    Title
    Change in Ocular Surface Disease Index's Environmental Trigger (OSDI-ET) subscale score from baseline
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Systemic safety: adverse events, clinical laboratory; and vital signs
    Time Frame
    12 weeks
    Title
    Ocular tolerability and safety: incidence and severity of ocular adverse events during the study (ophthalmic examination, ocular tolerability assessment and/ or adverse events spontaneously reported)
    Time Frame
    12 weeks
    Title
    Schirmer test without anesthesia: Change in length of wetting from baseline at Days 7, 14, 28, and Week 8; Response rate (percentage of subjects who achieve ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Response rate (percentage of
    Time Frame
    12 weeks
    Title
    subjects who achieve increase of ≥10mm wetting) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of change from baseline of ≥10mm wetting;Time to achievement of ≥10mm wetting
    Time Frame
    12 weeks
    Title
    Corneal staining:Change from baseline at Days 7, 14, 28 and Weeks 8 and 12;Response rate (percentage of subjects who demonstrate 100% clearing of corneal staining) at Days 7, 14, 28 and Weeks 8 and 12;Time to achievement of 100% clearing of corneal
    Time Frame
    12 weeks
    Title
    staining
    Time Frame
    12 weeks
    Title
    Ocular Surface Disease Index (OSDI): Change in the OSDI total score and three subscale scores (the Ocular Symptoms, Vision-Related Function, and Environmental Triggers) from baseline at Days 7, 14, 28, and Weeks 8 and 12 (except ET subscale
    Time Frame
    12 weeks
    Title
    score); Response rate (percentage of subjects who demonstrating ≥10 unit decrease in OSDI total score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥10 unit decrease in OSDI total score
    Time Frame
    12 weeks
    Title
    Modified Ocular Comfort Index (mOCI): Change in the OCI score, the Dry Eye Symptoms (DES) and Symptom Interference (SI) subscales scores from baseline at Days 7, 14, 28 and Weeks 8 and 12; OCI Response rate (percentage of subjects who demonstrating
    Time Frame
    12 weeks
    Title
    ≥3 point decrease from baseline in the OCI score) at Days 7, 14, 28, and Weeks 8 and 12; Time to achievement of ≥3 point decrease from baseline in the OCI score
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females aged 18 years or older at time of consent Diagnosis of dry eye disease, characterized by subjective symptoms of dry eye for at least 6 months, Schirmer test without anesthesia: =>1 mm and =<7 mm, sum of corneal fluorescein staining score of =>4 (NEI Scale), and subject grading total score of => 23 on the OSDI Exclusion Criteria: Planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of the Screening visit or during study Ocular disorders that may confound interpretation of study results such as significant corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal tear spreading, including but not limited to the following: abnormal lid function, lid position, or blink rate, that in the opinion of the investigator is clinically significant, history of herpetic keratopathy Lacrimal punctal occlusion (plugs or cautery) within 2 months of the Screening visit Contact lens wear within 2 weeks of the Screening visit and/or during study participation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921066&StudyName=A%20Study%20Of%20Tasocitinib%20In%20Dry%20Eye%20Subjects
    Description
    To obtain contact information for a study center near you, click here.

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    A Study Of Tasocitinib In Dry Eye Subjects

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