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

Dry Eye Clinical Trial

Official title: A Phase Ⅱ, Multicenter, Randomized, Single-blind, Positive-controlled, Dose-finding Study to Assess the Efficacy and Safety of CsA Ophthalmic Gel in Subjects With Moderate to Severe Aqueous-Deficient Dry Eye (ADDE)

Status Completed

Clinical Trial 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.

Clinical Trial Description

A multicenter, randomized, single-blind, positive controlled exploratory study will be conducted with cyclosporine A ophthalmic emulsion as the control drug.

The experimental drugs were divided into three groups:

Treatment group A: CsA eye gel: 0.3 g: 0.15 mg, once daily； Treatment group B: CsA eye gel:

0.3 g: 0.15 mg, twice daily, interval of about 12 hours； Treatment group C: CsA eye gel: 0.3 g: 0.3 mg, once daily. One drop into each eye when you use it.

Control group: CsA emulsion: 0.4 ml: 0.2 mg. One drop into the eye, 2 times daily with an interval for 12 hours. ;

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

• NCT number: NCT03676335
• Study type: Interventional
• Source: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: May 9, 2018
• Completion date: December 12, 2019