NCT05370495

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Seinda Pharmaceutical Guangzhou Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	SY-201 Ophthalmic Solution 2.0%	SY-201 Ophthalmic Solution 2.0%
DRUG	SY-201 Ophthalmic Solution 1.0%	SY-201 Ophthalmic Solution 1.0%
DRUG	SY-201 Ophthalmic Solution 0.5%	SY-201 Ophthalmic Solution 0.5%
DRUG	SY-201 Ophthalmic Solution Vehicle	SY-201 Ophthalmic Solution Vehicle

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-03-24
• Completion: 2023-03-24
• First posted: 2022-05-11
• Last updated: 2024-11-26
• Results posted: 2024-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study