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A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye

Dry Eye Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of HBM9036 Ophthalmic Solution Versus Placebo in Subjects With Moderate to Severe Dry Eye

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

Clinical Trial Description

HBM9036 is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment. A total of 100 subjects are expected to be randomized. Subjects will be randomized 1:1 at Visit 2 to HBM9036 Ophthalmic Solution or placebo group, bilaterally BID for eight weeks. The primary efficacy endpoint is sign changes from baseline in change from pre- to post-CAE inferior corneal staining score (ICSS) of the study eye evaluated at week 8 . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04092907
Study type Interventional
Source Harbour BioMed (Guangzhou) Co. Ltd.
Contact
Status Completed
Phase Phase 2
Start date March 22, 2019
Completion date July 10, 2019
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