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

Tarsier Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Post Surgical Ocular Inflammation

Treatments

Drug: Placebo eye drops

Drug: TRS01 eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT04222725

Grant Agreement Number 879598 (Other Grant/Funding Number)

Tarsius 2020

2019-004327-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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