Title
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation
Phase
Phase 1/Phase 2Lead Sponsor
Tarsius PharmaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Post Surgical Ocular InflammationIntervention/Treatment
TRS01 eye drops TRS01 eye drops TRS01 eye drops ...Study Participants
37The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.
Dosed 4 times a day (QID)
Dosed QID
Dosed QID
Dosed QID
Inclusion Criteria: Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are: 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. Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery. Have vision ≥ 20/200 in the non-study eye. Able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops. Have no known sensitivity /allergy to the TRS01 or formulation excipients. Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol Randomization inclusion criteria as specified per protocol. Exclusion Criteria: Scheduled to undergo cataract surgery in the non-study eye for the duration of the study. Receiving specific medication/interventions as specified per protocol
| Event Type | Organ System | Event Term | TRS01 Low Dose | TRS01 Medium Dose | TRS01 High Dose | Placebo |
|---|
Number of adverse events that occurred during the study
