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

NCT06766357 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-07-28

No results posted yet for this study

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.

Conditions

  • Moderate to Severe Dry Eye

Interventions

DRUG

Cyclosporine ophthalmic gel

Administer to eyes

DRUG

Cyclosporine ophthalmic gel vehicle

Administer to eyes

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Zuguo Liu · Xiamen Eye Center of Xiamen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2026-02-28
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06766357 on ClinicalTrials.gov