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

Tarsier Pharma

Status and phase

Completed

Phase 3

Conditions

Uveitic Glaucoma

Non-infectious Anterior Uveitis

Treatments

Drug: FDA approved steroid eye drop (masked)

Drug: TRS01

Study type

Interventional

Funder types

Industry

Identifiers

NCT05042609

TRS4Vision

Details and patient eligibility

About

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

Enrollment

142 patients

Sex

All

Ages

Under 75 years old

Volunteers

No 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.