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

Last updated: May 29, 2024
Sponsor: HanAll BioPharma Co., Ltd.
Overall Status: Suspended

Phase

3

Condition

Dry Eyes

Sjogren's Syndrome

Eyelid Inflammation

Treatment

Vehicle

tanfanercept

Clinical Study ID

NCT06400589
HL036-DED-US-P303
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andassessments

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

Exclusion

Exclusion Criteria:

  1. Have an uncontrolled systemic disease

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

Study Design

Total Participants: 750
Treatment Group(s): 2
Primary Treatment: Vehicle
Phase: 3
Study Start date:
May 01, 2024
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • HanAll Site #1

    Delray Beach, Florida 33484
    United States

    Site Not Available

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