Title
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
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.
Phase
Phase 1/Phase 2Lead Sponsor
Tarsius PharmaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Non-infectious Anterior UveitisIntervention/Treatment
TRS01 eye drops TRS01 eye dropsStudy Participants
16The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.
Dosed four times a day (QID)
Dosed four times a day (QID)
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
| Event Type | Organ System | Event Term | TRS01 Low Dose | TRS01 High Dose |
|---|
Number of patients experiencing Adverse Events during the study
