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

Phase 1

Completed

Interventions: 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

Brief Summary: 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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

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 [National Eye Institute (NEI) grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
Have a history of glaucoma or intraocular pressure (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.

Arm && Interventions

Group	Intervention	Description
SY-201 Ophthalmic Solution 2.0%	SY-201 Ophthalmic Solution 2.0%	SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 1.0%	SY-201 Ophthalmic Solution 1.0%	SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 0.5%	SY-201 Ophthalmic Solution 0.5%	SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution Vehicle	SY-201 Ophthalmic Solution Vehicle	SY-201 Ophthalmic Solution Vehicle

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60	60 days	Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).
Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60	60 days	Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60	60 days	Cornea is divided into 5 regions. The central region is graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)).
Change From Baseline in Symptom Severity Score (Subscale) at Day 60	60 days	Symptom severity score sub scale is measured of severity scale of symptoms associated with dry eye using visual analog scale (0 (none) -100 (severe)). This self reported Dry eye symptoms severity score sub scale measures the extent of any ocular discomfort (symptoms), including but not limited to dryness, ocular pain or other type of symptoms.