Back to resultsA Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AXR-159
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18 years of age or older at screening visit
- Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
- Reported history of dry eye for at least 6 months
- Corneal fluorescein staining score ≥ 2
- Eye dryness score ≥ 40
- Total Ocular Surface Disease Index (OSDI) score > 18
Exclusion Criteria:
- Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
- Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure.
- Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity
- BCVA worse than 20/100 in either eye
- Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
- Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells
- Patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea
- Recent (within the past 3 months) ocular surgery, trauma or herpes
- Use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study
Sites / Locations
- Andover Eye Associates
- Andover Eye Associates
- Total Eye Care, P.A.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AXR-159 Ophthalmic Solution 3 mg/mL
AXR-159 Ophthalmic Solution 30 mg/mL
AXR-159 Ophthalmic Solution 50 mg/mL
AXR-159 Ophthalmic Solution Vehicle
Arm Description
AXR-159 Low Dose
AXR-159 Mid Dose
AXR-159 High Dose
Control Group
Outcomes
Primary Outcome Measures
Inferior Corneal Staining Score
Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome.
Eye Dryness
Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome.
Secondary Outcome Measures
Total Ocular Surface and Disease Index (OSDI) © for Dry Eye
Change from baseline in OSDI © score on a subject level. The 12-question OSDI © is assessed on a total scale from 0 to 100, where higher scores represent greater disability. A greater negative change from baseline indicates a better outcome.
Schirmer's Test
Change from baseline in Schirmer's Test score in the study eye. Unanesthetized Schirmer's Test measures the length of the moistened area of a test strip, placed in the lower temporal lid margin of each eye, in mm following a 5-minute exposure period. Greater positive numbers indicate a better outcome.
Tear Film Break-up Time (TBUT)
Change from baseline in the study eye with a greater positive increase indicating a better outcome. Following the instillation of a sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye and several blinks over 30 seconds, the examiner monitored the integrity of the tear film with the aid of a slit lamp, noting the time it takes to form micelles from the time that the eye is opened. TBUT was measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. Values reported are for the study eye.
Conjunctival Redness Score
Change from baseline of Ora Calibra® Conjunctival Redness Scale for Dry Eye. Scores range from 0 to 4 with 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; with higher numbers indicating more conjunctival redness. Greater negative numbers indicate a better outcome. Values reported are for the study eye.
Total Lissamine Green Conjunctival Staining
Change from baseline of Oxford Grading Scale measuring staining within a range from 0-5 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe, 5=Confluent) for each panel (temporal and nasal) and 0-10 as the sum of both panel scores for the total exposed inter-palpebral conjunctiva. Larger negative numbers indicate reduced staining and a better outcome. Values reported are for the study eye.
Full Information
NCT ID
NCT03598699
First Posted
July 16, 2018
Last Updated
September 21, 2023
Sponsor
AxeroVision, Inc.
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03598699
Brief Title
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
Official Title
A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution 3 mg/mL, 30 mg/mL, and 50 mg/mL in Patients With Dry Eye Disease (DED)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
January 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AxeroVision, Inc.
Collaborators
ORA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).
Detailed Description
Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.
A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month double-masked treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AXR-159 Ophthalmic Solution 3 mg/mL
Arm Type
Experimental
Arm Description
AXR-159 Low Dose
Arm Title
AXR-159 Ophthalmic Solution 30 mg/mL
Arm Type
Experimental
Arm Description
AXR-159 Mid Dose
Arm Title
AXR-159 Ophthalmic Solution 50 mg/mL
Arm Type
Experimental
Arm Description
AXR-159 High Dose
Arm Title
AXR-159 Ophthalmic Solution Vehicle
Arm Type
Placebo Comparator
Arm Description
Control Group
Intervention Type
Drug
Intervention Name(s)
AXR-159
Intervention Description
AXR-159 Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
AXR-159 Ophthalmic Solution Vehicle
Primary Outcome Measure Information:
Title
Inferior Corneal Staining Score
Description
Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome.
Time Frame
Month 3
Title
Eye Dryness
Description
Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Total Ocular Surface and Disease Index (OSDI) © for Dry Eye
Description
Change from baseline in OSDI © score on a subject level. The 12-question OSDI © is assessed on a total scale from 0 to 100, where higher scores represent greater disability. A greater negative change from baseline indicates a better outcome.
Time Frame
Month 3
Title
Schirmer's Test
Description
Change from baseline in Schirmer's Test score in the study eye. Unanesthetized Schirmer's Test measures the length of the moistened area of a test strip, placed in the lower temporal lid margin of each eye, in mm following a 5-minute exposure period. Greater positive numbers indicate a better outcome.
Time Frame
Month 3
Title
Tear Film Break-up Time (TBUT)
Description
Change from baseline in the study eye with a greater positive increase indicating a better outcome. Following the instillation of a sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye and several blinks over 30 seconds, the examiner monitored the integrity of the tear film with the aid of a slit lamp, noting the time it takes to form micelles from the time that the eye is opened. TBUT was measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. Values reported are for the study eye.
Time Frame
Month 3
Title
Conjunctival Redness Score
Description
Change from baseline of Ora Calibra® Conjunctival Redness Scale for Dry Eye. Scores range from 0 to 4 with 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; with higher numbers indicating more conjunctival redness. Greater negative numbers indicate a better outcome. Values reported are for the study eye.
Time Frame
Month 3
Title
Total Lissamine Green Conjunctival Staining
Description
Change from baseline of Oxford Grading Scale measuring staining within a range from 0-5 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe, 5=Confluent) for each panel (temporal and nasal) and 0-10 as the sum of both panel scores for the total exposed inter-palpebral conjunctiva. Larger negative numbers indicate reduced staining and a better outcome. Values reported are for the study eye.
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 years of age or older at screening visit
Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
Reported history of dry eye for at least 6 months
Corneal fluorescein staining score ≥ 2
Eye dryness score ≥ 40
Total Ocular Surface Disease Index (OSDI) score > 18
Exclusion Criteria:
Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure.
Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity
BCVA worse than 20/100 in either eye
Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells
Patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea
Recent (within the past 3 months) ocular surgery, trauma or herpes
Use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L Torkildson, MD
Organizational Affiliation
Andover Eye Associates, 138 Haverhill Street, Andover MA 01810
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth R Kenyon, MD
Organizational Affiliation
Andover Eye Associates, 675 Paramount Drive, Raynham, MA 02767
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene McLaurin, MD
Organizational Affiliation
Total Eye Care, P.A., 6060 Primacy Parkway, Memphis, TN 38119
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Andover Eye Associates
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
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