Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye

Study Overview
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Brief Summary
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The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Official Title
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A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1.0% and 2.5% Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: cis-UCA ophthalmic solution 1.0%
* Drug: cis-UCA ophthalmic solution 2.5%
* Drug: Placebo ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Have a subject reported history of dry eye; Have a history of use or desire to use eye drops. Key Exclusion Criteria: Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters; Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Have used Restasis® within 30 days of Visit 1; Have any planned ocular and/or lid surgeries over the study period; Be a woman who is pregnant, nursing or planning a pregnancy; Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential; Have a known allergy and/or sensitivity to the study drug or its components; Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1; Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cis-UCA ophthalmic solution 1.0%<br>One drop in each eye | Drug: cis-UCA ophthalmic solution 1.0%<br> <br> |
| Active Comparator: cis-UCA ophthalmic solution 2.5%<br>One drop in each eye | Drug: cis-UCA ophthalmic solution 2.5%<br> <br> |
| Placebo Comparator: Placebo ophthalmic solution<br>One drop in each eye | Drug: Placebo ophthalmic solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Fluorescein Staining |  | Day 29 | 
| Symptom Score |  | Day 22 to 28 |