A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Phase 1
Completed
- Conditions
- Non-infectious Anterior Uveitis
- Interventions
- Drug: TRS01 eye drops
- Registration Number
- NCT04222712
- Lead Sponsor
- Tarsier Pharma
- Brief Summary
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- 18 years of age or older
- Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
- Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.
An eligible subject must have:
- Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
- Must have vision ≥ 20/40 in the non-study eye.
- Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.
Exclusion Criteria
- Any form of infectious uveitis
- Active retinitis
- Cancer or melanoma that is actively treated with immunotherapy
- Pregnancy / lactation
- Receiving specific medication/interventions as specified per protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TRS01 low dose TRS01 eye drops - TRS01 high dose TRS01 eye drops -
- Primary Outcome Measures
Name Time Method Assessment of Both Systemic and Ocular Adverse Events 10 weeks Number of patients experiencing Adverse Events during the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
San Antonio
🇺🇸San Antonio, Texas, United States
Palisades Park
🇺🇸Palisades Park, New Jersey, United States