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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.25% tanfanercept

0.25% tanfanercept ou bid for 12 weeks

Group Type EXPERIMENTAL

tanfanercept

Intervention Type DRUG

TNF inhibitor

1.0% tanfanercept

1.0% tanfanercept ou bid for 12 weeks

Group Type EXPERIMENTAL

tanfanercept

Intervention Type DRUG

TNF inhibitor

Vehicle

Vehicle ou bid for 12 weeks

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Same composition as tanfanercept but without the active ingredient

Interventions

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tanfanercept

TNF inhibitor

Intervention Type DRUG

Vehicle

Same composition as tanfanercept but without the active ingredient

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No