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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06400589

Acronym

VELOS-4

Enrollment

750

Registered

2024-05-06

Start date

2024-05-01

Completion date

2025-08-31

Last updated

2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Brief 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.

Interventions

DRUGtanfanercept

TNF inhibitor

DRUGVehicle

Same composition as tanfanercept but without the active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026