Safety and Efficacy of TOP1630 for Dry Eye Syndrome

Study Overview
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Brief Summary
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In subjects with Dry Eye Syndrome: The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo. The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Detailed Description
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This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome. Eligible subjects will be randomized double masked to either TOP1630 or placebo. Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort. Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy

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

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: TOP1630 Ophthalmic Solution
* Drug: Placebo to TOP1630 Ophthalmic Solution


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; Additionally for Part 2 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: Active<br>TOP1630 Ophthalmic Solution | Drug: TOP1630 Ophthalmic Solution<br>* Bilateral ocular drug administration<br>|
| Placebo Comparator: Placebo<br>Placebo (Vehicle) Ophthalmic Solution | Drug: Placebo to TOP1630 Ophthalmic Solution<br>* Bilateral ocular drug administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual Acuity will be measured using the EDTRS chart to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame | 
| Slit-lamp Biomicroscopy | Slit lamp biomicroscopy exams will be performed to assess any changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame | 
| Vital Signs | Blood Pressure, Pulse and SPo2 will be performed to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame | 
| Drop Comfort Assessment | The comfort of the eye drop will be performed to assess changes from baseline | Part 1: 12 days time frame | 
| Intraocular pressure | a non-contact tonometer will be used to perform IOP to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame | 
| Corneal sensitivity | The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline | Part 1: 12 days time frame; Part 2: 35 days time frame | 
| Undilated Fundoscopy | Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline | Part 2: 35 days time frame | 
| Adverse events | Adverse event questioning | Part 1: 12 days time frame; Part 2: 35 days time frame | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular discomfort | Ocular discomfort severity assessments | Part 2: 35 days time frame | 
| Dry eye symptoms | Dry eye syndrome symptom assessments | Part 2: 35 days time frame | 
| Dry eye signs | Dry eye syndrome conjunctival staining assessments | Part 2: 35 days time frame | 
| Tear film break up time | Tear film break up time measured after instillation of sodium fluorescein solution | Part 2: 35 days time frame | 
| Schirmer's test | Measurement of Schirmer test strips | Part 2: 35 days time frame | 
| Impression cytology | Impression cytology | Part 2: 35 days time frame | 
| Daily symptom assessment | Daily symptom assessment using diary cards | Part 2: 35 days time frame |