A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation

Tarsier Pharma5 sites in 1 country37 target enrollmentFebruary 1, 2020

ConditionsPost Surgical Ocular Inflammation

InterventionsTRS01 eye drops Placebo eye drops

DrugsTRS01 eye drops Placebo eye drops

Overview

Phase: Phase 1
Intervention: TRS01 eye drops
Conditions: Post Surgical Ocular Inflammation
Sponsor: Tarsier Pharma
Enrollment: 37
Locations: 5
Primary Endpoint: Assessment of Both Systemic and Ocular Adverse Events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The 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.

Registry

clinicaltrials.gov

Start Date

February 1, 2020

End Date

July 17, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tarsier Pharma

Responsible Party

Sponsor

Eligibility Criteria

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