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A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

NCT05042609•Tarsier Pharma

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma

Eligibility

Age

0 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive.
•Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment.
•Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).

Exclusion Criteria

•Pregnant or breastfeeding females or females.
•History of or active significant ocular disease in either eye.
•Uncontrolled intraocular pressure (IOP; defined as \>27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating.
•Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment.
•Cancer or melanoma that is actively treated with immunotherapy.
•Certain clinically significant systemic diseases or conditions.
•Receiving specific medication/interventions as specified per protocol.

Locations (30)

La Jolla

La Jolla, California, United States

Los Angeles

Los Angeles, California, United States

Los Angeles 2

Los Angeles, California, United States

Aurora

Aurora, Colorado, United States

Lakewood

Lakewood, Colorado, United States

Jacksonville

Jacksonville, Florida, United States

Winter Haven

Winter Haven, Florida, United States

Marietta

Marietta, Georgia, United States

Boston

Boston, Massachusetts, United States

Waltham

Waltham, Massachusetts, United States

Key Dates

Start Date

September 20, 2021

Primary Completion Date

June 29, 2023

Completion Date

June 29, 2023

Last Updated

August 28, 2023

Enrollment

142

ACTUAL participants

Conditions

Non-infectious Anterior UveitisUveitic Glaucoma

Interventions

TRS01

DRUG

FDA approved steroid eye drop (masked)

DRUG

Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis

NCT07285070

Non-infectious Anterior Uveitis

View study

COMPLETEDPHASE1/PHASE2

A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

NCT04222712

Non-infectious Anterior Uveitis

View study

COMPLETED

Aqueous Humor Dynamics and Hypertensive Uveitis

NCT02765308

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.