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

Dry Eye Clinical Trial

— VELOS-4  

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 Details — Status: Suspended

Administrative data

• NCT number: NCT06400589
• Other study ID #: HL036-DED-US-P303
• Status: Suspended
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: HanAll BioPharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 750
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Are at least 18 years of age

2. Provide written informed consent

3. Are willing to attend all study visits and able to comply with study procedures and assessments

4. Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1

Exclusion Criteria:

1. Have an uncontrolled systemic disease

2. Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• tanfanercept
TNF inhibitor
• Vehicle
Same composition as tanfanercept but without the active ingredient

Locations

Country	Name	City	State
United States	HanAll Site #1	Delray Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comfort Score (Exploratory)	Study product instillation score at each post-baseline visit	2 weeks, 4 weeks, 8 weeks
Primary	Schirmer Test	The proportion of participants with improvement from baseline in unanesthetized Schirmer	12 weeks
Secondary	Schirmer Test	Change from baseline in unanesthetized Schirmer test score	2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary	Symptom Assessment in Dry Eye	Change from baseline in Symptom Assessment in Dry Eye	2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary	VAS	Change from baseline in Eye dryness, burning/stinging, itching, foreign body sensation, eye discomfort, photophobia, and pain on the visual analog scale (VAS)	2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary	Conjunctival redness	Change from baseline in conjunctival redness on BHVI bulbar redness scale	2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary	Corneal staining	Change from baseline in corneal staining on NEI scale	2 weeks, 4 weeks, 8 weeks, 12 weeks