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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Post Surgical Ocular Inflammation

In brief

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.

Key facts

Study ID

NCT04222725

Run by

Tarsier Pharma

People needed

37

Starts

2020-02-01

Expected to finish

2020-07-17

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
• Receiving specific medication/interventions as specified per protocol

Where it is running

• Inglewood — Inglewood, California, United States
• Petaluma — Petaluma, California, United States
• Washington, MO — Washington, Missouri, United States
• New York — New York, New York, United States
• Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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