NCT06400589

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

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)

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: HanAll BioPharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	tanfanercept	TNF inhibitor
DRUG	Vehicle	Same composition as tanfanercept but without the active ingredient

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-05-06
• Last updated: 2024-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study