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

Phase 1

Completed

• Conditions: Post Surgical Ocular Inflammation
• Interventions: Drug: Placebo eye drops; Drug: TRS01 eye drops

• Registration Number: NCT04222725
• Lead Sponsor: Tarsier Pharma

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Study Start: 2020-02-01
• Primary Completion: 2020-07-17
• Study Completion: 2020-07-17
• Results First Submitted: 2021-09-10
• Results First Submitted QC: 2021-10-13
• Last Update Submitted: 2021-10-13
• Results First Posted: 2021-10-14
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo eye drops	-
TRS01 medium dose	TRS01 eye drops	-
TRS01 high dose	TRS01 eye drops	-
TRS01 low dose	TRS01 eye drops	-

Primary Outcome Measures

Name	Time	Method
Assessment of Both Systemic and Ocular Adverse Events	14 days	Number of adverse events that occurred during the study

Trial Locations

Locations (5)

Inglewood; 🇺🇸 Inglewood, California, United States

New York; 🇺🇸 New York, New York, United States

Petaluma; 🇺🇸 Petaluma, California, United States

Washington, MO; 🇺🇸 Washington, Missouri, United States

Cincinnati; 🇺🇸 Cincinnati, Ohio, United States