RecruitingPhase 3NCT06766357

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

A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of Cyclosporin Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease

Sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Enrollment

360 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Moderate to Severe Dry Eye

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclosporine ophthalmic gel and a drug called Cyclosporine ophthalmic gel vehicle for people with moderate to severe dry eye. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclosporine ophthalmic gel

Administer to eyes

DRUGCyclosporine ophthalmic gel vehicle

Administer to eyes

Locations(1)

Xiamen Eye Center of Xiamen University

Xiamen, Fujian, China

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NCT06766357