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Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye

NCT03676335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-05-08

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 tear deficiency dry eye with different dosage, frequency and concentration, and to preliminarily determine the optimal dosage, frequency and concentration, so as to provide a theoretical basis for the design of follow-up clinical studies.

Conditions

  • Dry Eye

Interventions

DRUG

CsA eye gel

The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg

DRUG

CsA for eye emulsion

The CsA for eye emulsion of 0.4 ml: 0.2 mg

DRUG

Hypromellose Eye Drops

Hypromellose Eye Drops of 15ml：75mg, 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
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2019-06-30
Completion
2019-12-12

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 NCT03676335 on ClinicalTrials.gov