NCT04633213

A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye

A Phase 3, Multicenter, Randomized, Double-Blinded and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HBM9036 (HL036) Ophthalmic Solution Compared to Placebo in Chinese Subjects With Moderate and Severe Dry Eye

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 674 (estimated)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the safety and efficacy of 0.25% HBM9036 (HL036) Ophthalmic Solution to placebo for the treatment of the Chinese subjects with moderate and severe dry eye.

Detailed description

Inhibitors for tumor necrosis factor (TNF) have been widely used in clinical practice. Such class of medications have been approved for rheumatoid arthritis, ulcerative colitis, and uveitis. HBM9036 (HL036) is a molecularly engineered TNFR1 fragment, and molecule fragmentation and engineering techniques are applied for enhanced tissue distribution, increased stability and potency. In multiple early stage studies including preclinical studies, HBM9036 (HL036) has demonstrated the safety and efficacy in the therapy for moderate and severe dry eye. As a phase 3 confirmational study, this study is to evaluate the safety and efficacy of 0.25% HBM9036 (HL036) ophthalmic solution compared to placebo in Chinese subjects with moderate and severe dry eye.

Conditions

• Dry Eye

Interventions

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

Timeline

• Start date: 2021-02-24
• Primary completion: 2022-12-31
• Completion: 2023-04-07
• First posted: 2020-11-18
• Last updated: 2023-02-24

Locations

1 site across 1 country: China