Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).

Official Title
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A Phase 2, Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Dose-Response, Parallel-Group Study of SY-201 Ophthalmic Solution Versus Vehicle Control in Subjects With Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: SY-201 Ophthalmic Solution 2.0%
* Drug: SY-201 Ophthalmic Solution 1.0%
* Drug: SY-201 Ophthalmic Solution 0.5%
* Drug: SY-201 Ophthalmic Solution Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Provide written informed consent prior to any study-related procedures. Are 18 years of age or older. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study. Have a BCVA in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1. Exclusion Criteria: Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit 1. Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial Have corneal erosive disease (e.g., confluent staining [NEI grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye. Have a history of glaucoma or IOP >25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: Double-masked, parallel, randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SY-201 Ophthalmic Solution 2.0%<br>SY-201 Ophthalmic Solution 2.0% | Drug: SY-201 Ophthalmic Solution 2.0%<br>* SY-201 Ophthalmic Solution 2.0%<br>|
| Experimental: SY-201 Ophthalmic Solution 1.0%<br>SY-201 Ophthalmic Solution 1.0% | Drug: SY-201 Ophthalmic Solution 1.0%<br>* SY-201 Ophthalmic Solution 1.0%<br>|
| Experimental: SY-201 Ophthalmic Solution 0.5%<br>SY-201 Ophthalmic Solution 0.5% | Drug: SY-201 Ophthalmic Solution 0.5%<br>* SY-201 Ophthalmic Solution 0.5%<br>|
| Placebo Comparator: SY-201 Ophthalmic Solution Vehicle<br>SY-201 Ophthalmic Solution Vehicle | Drug: SY-201 Ophthalmic Solution Vehicle<br>* SY-201 Ophthalmic Solution Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total corneal fluorescein staining | As measured by modified National Eye Institute scale (0 (none) to 20 (severe)) | 60 days | 
| Eye dryness score | As measure by visual analog scale (0 (none) to 100 (severe)) | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Frequency and severity of ocular and non-ocular adverse events | 60 days |