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

Tarsier Pharma29 sites in 3 countries142 target enrollmentSeptember 20, 2021

ConditionsNon-infectious Anterior Uveitis Uveitic Glaucoma

InterventionsTRS01 FDA approved steroid eye drop (masked)

DrugsTRS01 FDA approved steroid eye drop (masked)

Overview

Phase: Phase 3
Intervention: TRS01
Conditions: Non-infectious Anterior Uveitis
Sponsor: Tarsier Pharma
Enrollment: 142
Locations: 29
Primary Endpoint: Anterior Chamber Cell (ACC) grade on Day 28
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 20, 2021

End Date

June 29, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tarsier Pharma

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

TRS01

Intervention: TRS01

Active comparator

Intervention: FDA approved steroid eye drop (masked)

Outcomes

Primary Outcomes

Anterior Chamber Cell (ACC) grade on Day 28

Time Frame: 28 days

For FDA submission: the proportion of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. For submission to European Medicines Agency (EMA) related countries: the proportion of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.