Overview

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

Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seinda Pharmaceutical Guangzhou Corporation
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
- Inclusion Criteria

1. Provide written informed consent prior to any study-related procedures.

2. Are 18 years of age or older.

3. Are willing and able to follow instructions and can be present for the required
study visits for the duration of the study.

4. 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:

1. Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit 1.

2. 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

3. 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.

4. Have a history of glaucoma or IOP >25 mmHg at Visit 1 or a history of elevated IOP
(>25 mmHg) in either eye.

5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.