A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.

Official Title
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A Phase 2, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: A197 Ophthalmic Solution
* Drug: A197 Vehicle Control
* Drug: Active Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained prior to any study-related assessments Have a history of Dry Eye Disease in both eyes for at least 12 months prior to Visit 1 Willing and able to follow instructions and can be present for required study visits Exclusion Criteria: Women who are pregnant or breastfeeding Use of topical ophthalmic medications, artificial tears, eye drops and gels in either eye Use of contact lenses within 90 days prior to Visit 1 and throughout the study Have had an ocular infection in either eye within 90 days prior to Visit 1

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A197 Ophthalmic Solution, High Dose<br> | Drug: A197 Ophthalmic Solution<br>* A197 Ophthalmic Solution<br>|
| Experimental: A197 Ophthalmic Solution, Low Dose<br> | Drug: A197 Ophthalmic Solution<br>* A197 Ophthalmic Solution<br>|
| Placebo Comparator: A197 Vehicle Control<br> | Drug: A197 Vehicle Control<br>* A197 Vehicle Control<br>|
| Active Comparator: Active Comparator<br> | Drug: Active Comparator<br>* Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total corneal fluorescein staining (CFS) | Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in eye dryness via the Visual Analogue Scale (VAS) | Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms. | 12 Weeks | 
| Change from baseline in lissamine green conjunctival staining (LGCS) | Lissamine green conjunctival staining (LGCS) is graded based on the NEI Scale. The NEI scale divides the conjunctiva in 6 regions with the score for each region ranging from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 6 regions ranging from 0-18. | 12 Weeks | 
| Change from baseline in bulbar conjunctival hyperemia (CCLRU) | Bulbar conjunctival hyperemia is graded based on the Cornea and Contact Lens Research Unit (CCLRU) grading scale where 0 corresponds to none, 4 corresponds to severe. | 12 Weeks |