Clinical Trial

A Study of the Efficacy and Safety of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease

Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated July 28, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-03; most recent amendment 2025-07-25.
Status change: Not Yet Recruiting → Recruiting 2025-07-25
Trial Details
NCT Number NCT06766357
Lead Sponsor Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Conditions Moderate to Severe Dry Eye
Enrollment 360 participants
Start Date 2025-04-03
Primary Completion 2026-02 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-28