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Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease

NCT04541888 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2022-04-29

No results posted yet for this study

Summary

The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe dry eye disease .

Conditions

  • Dry Eye

Interventions

DRUG

CsA Ophthalmic Gel

The CsA eye gel of 0.3 g: 0.15 mg

DRUG

Placebo

Placebo

DRUG

Hypromellose Eye Drop

Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • shiyou zhou, PHD · Ophthalmological Center of Zhongshan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-05
Primary Completion
2021-08-16
Completion
2021-10-14

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04541888 on ClinicalTrials.gov