NCT04222712
Completed
Phase 1
A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.
Tarsier Pharma2 sites in 1 country16 target enrollmentFebruary 1, 2020
Overview
- Phase
- Phase 1
- Intervention
- TRS01 eye drops
- Conditions
- Non-infectious Anterior Uveitis
- Sponsor
- Tarsier Pharma
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Assessment of Both Systemic and Ocular Adverse Events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.
Investigators
Eligibility Criteria
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
Arms & Interventions
TRS01 low dose
Intervention: TRS01 eye drops
TRS01 high dose
Intervention: TRS01 eye drops
Outcomes
Primary Outcomes
Assessment of Both Systemic and Ocular Adverse Events
Time Frame: 10 weeks
Number of patients experiencing Adverse Events during the study
Study Sites (2)
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