A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease
- Registration Number
- NCT06400589
- Lead Sponsor
- HanAll BioPharma Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 750
- Are at least 18 years of age
- Provide written informed consent
- Are willing to attend all study visits and able to comply with study procedures and assessments
- Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1
- Have an uncontrolled systemic disease
- Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Vehicle ou bid for 12 weeks 1.0% tanfanercept tanfanercept 1.0% tanfanercept ou bid for 12 weeks 0.25% tanfanercept tanfanercept 0.25% tanfanercept ou bid for 12 weeks
- Primary Outcome Measures
Name Time Method Schirmer Test 12 weeks The proportion of participants with improvement from baseline in unanesthetized Schirmer
- Secondary Outcome Measures
Name Time Method Schirmer Test 2 weeks, 4 weeks, 8 weeks, 12 weeks Change from baseline in unanesthetized Schirmer test score
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)
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
Symptom Assessment in Dry Eye 2 weeks, 4 weeks, 8 weeks, 12 weeks Change from baseline in Symptom Assessment in Dry Eye
Trial Locations
- Locations (1)
HanAll Site #1
🇺🇸Delray Beach, Florida, United States