Study of TOP1630 for Dry Eye Syndrome

Study Overview
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Brief Summary
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In subjects with Dry Eye Syndrome (DES): The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

Detailed Description
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This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES). Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.

Official Title
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A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: TOP1630 0.1% Ophthalmic Solution TID OU
* Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Have a reported history of dry eye; Have a history of use of eye drops for dry eye symptoms; Symptoms of dry eye syndrome including: Ocular discomfort Conjunctival redness Tear film break up time Schirmer test score Signs of dry eye syndrome including: Conjunctival staining score Exclusion Criteria: Have any clinically significant slit lamp findings at entry visit ; Be diagnosed with an ongoing ocular infection; Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI; Have any planned ocular and/or lid surgeries over the study period; Have an uncontrolled systemic disease; Be a woman who is pregnant, nursing or planning a pregnancy; Be a woman of childbearing potential who is not using an acceptable means of birth control; Have a known allergy and/or sensitivity to the test article 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

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 |
| --- | --- |
| Experimental: TOP1630 Ophthalmic Solution<br> | Drug: TOP1630 0.1% Ophthalmic Solution TID OU<br>* Bilateral ocular drug administration<br>|
| Placebo Comparator: Placebo to TOP1630 Ophthalmic Solution<br> | Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU<br>* Bilateral ocular drug administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular grittiness 6-point (0-5) scale | Ocular grittiness severity assessment | Day 29 | 
| Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region | Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal. | Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular discomfort 5-point (0-4) scale | Ocular discomfort severity assessment | Day 29 | 
| Ocular dryness 6-point (0-5) scale | Ocular dryness severity assessment | Day 29 | 
| Conjunctival lissamine green staining score 5-point (0-4) scale each region | Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal. | Day 29 | 
| Corneal lissamine green staining score 5-point (0-4) scale each region | Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central. | Day 29 | 
| Worst ocular symptom 6-point (0-5) scale | Most severe baseline symptom from reported daily symptoms | Day 29 |