NCT04092907

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed 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 .

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	HBM9036 0.25% Ophthalmic Solution	Ophthalmic Solution
DRUG	placebo	Ophthalmic Solution

Timeline

• Start date: 2019-03-22
• Primary completion: 2019-07-03
• Completion: 2019-07-10
• First posted: 2019-09-17
• Last updated: 2021-08-11
• Results posted: 2021-08-11

Locations

1 site across 1 country: China