Phase 2 N=37 Randomized Quadruple-blind Treatment

A Study of TRS01 in Participants With Post-surgical Ocular Inflammation

Post Surgical Ocular Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT04222725 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Assessment of Both Systemic and Ocular Adverse Events — 0; 3; 0; 0 Number of TEAE

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: TRS01 eye drops (Drug); Placebo eye drops (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tarsier Pharma
Primary completion: Jul 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Both Systemic and Ocular Adverse Events	0; 3; 0; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04222725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.