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Monoclonal Antibodies

1.0% tanfanercept for Dry Eye Syndrome (VELOS-4 Trial)

Phase 3

Recruiting

Research Sponsored by HanAll BioPharma Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 4 weeks, 8 weeks, 12 weeks

Awards & highlights

VELOS-4 Trial Summary

This trial aims to compare the effectiveness and safety of tanfanercept eye drops at different concentrations to a placebo in treating dry eye disease.

Who is the study for?

This trial is for adults over 18 with a self-reported history of Dry Eye Disease (DED) in both eyes for at least 6 months. Participants must consent to the study and commit to all visits and procedures. Those with uncontrolled diseases or recent investigational drug/device exposure cannot join.Check my eligibility

What is being tested?

The study aims to test the effectiveness and safety of two concentrations, 0.25% and 1.0%, of tanfanercept ophthalmic solution compared to a placebo (vehicle) in treating Dry Eye Disease.See study design

What are the potential side effects?

While specific side effects are not listed, typical reactions may include eye irritation, discomfort, redness, or allergic responses related to the use of eye drops.

VELOS-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

VELOS-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 4 weeks, 8 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 4 weeks, 8 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 4 weeks, 8 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Conjunctival redness

Corneal staining

Schirmer Test

+2 more

Other outcome measures

Comfort Score (Exploratory)

VELOS-4 Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 1.0% tanfanerceptExperimental Treatment1 Intervention

1.0% tanfanercept ou bid for 12 weeks

Group II: 0.25% tanfanerceptExperimental Treatment1 Intervention

0.25% tanfanercept ou bid for 12 weeks

Group III: VehiclePlacebo Group1 Intervention

Vehicle ou bid for 12 weeks

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

HanAll BioPharma Co., Ltd.Lead Sponsor

16 Previous Clinical Trials

1,979 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals participating in this study?

"Affirmative, details from clinicaltrials.gov indicate that this medical research endeavor is presently in search of participants. This study was initially shared on May 1st, 2024 and last revised on May 2nd, 2024. The trial aims to enlist a total of 750 patients from one designated site."

Answered by AI

Has the FDA given their approval for a 1.0% concentration of tanfanercept?

"Our team at Power has evaluated the safety of 1.0% tanfanercept to be a 3 on our scale, due to it being in Phase 3 trial with existing efficacy data and multiple rounds of safety data available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06400589.

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