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

May 14, 2024 updated by: HanAll BioPharma Co., Ltd.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.25% tanfanercept
0.25% tanfanercept ou bid for 12 weeks
Drug: tanfanercept
TNF inhibitor
Experimental: 1.0% tanfanercept
1.0% tanfanercept ou bid for 12 weeks
Drug: tanfanercept
TNF inhibitor
Placebo Comparator: Vehicle
Vehicle ou bid for 12 weeks
Drug: Vehicle
Same composition as tanfanercept but without the active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer Test
Time Frame: 12 weeks
The proportion of participants with improvement from baseline in unanesthetized Schirmer
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer Test
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Change from baseline in unanesthetized Schirmer test score
2 weeks, 4 weeks, 8 weeks, 12 weeks
Symptom Assessment in Dry Eye
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Change from baseline in Symptom Assessment in Dry Eye
2 weeks, 4 weeks, 8 weeks, 12 weeks
VAS
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
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
Conjunctival redness
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Change from baseline in conjunctival redness on BHVI bulbar redness scale
2 weeks, 4 weeks, 8 weeks, 12 weeks
Corneal staining
Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Change from baseline in corneal staining on NEI scale
2 weeks, 4 weeks, 8 weeks, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort Score (Exploratory)
Time Frame: 2 weeks, 4 weeks, 8 weeks
Study product instillation score at each post-baseline visit
2 weeks, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL036-DED-US-P303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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