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A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease — VELOS-4  

Dry Eye Clinical Trial

Official title:
A Phase 3, Multicenter, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% and 1.0% Compared to Vehicle in Participants With Dry Eye Disease (VELOS-4)

Clinical Trial Summary

The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.

Clinical Trial Description

The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06400589
Study type Interventional
Source HanAll BioPharma Co., Ltd.
Contact
Status Suspended
Phase Phase 3
Start date May 1, 2024
Completion date August 2025
View Details
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