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

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tarsier Pharma
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

• 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.