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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Non-infectious Anterior Uveitis, Uveitic Glaucoma

Intervention / Treatment
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* Drug: TRS01
* Drug: FDA approved steroid eye drop (masked)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRS01<br> | Drug: TRS01<br>* TRS01 eye drops Dosed four times a day (QID)<br>|
| Active Comparator: Active comparator<br> | Drug: FDA approved steroid eye drop (masked)<br>* FDA approved steroid eye drop Dosed four times a day (QID)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cell (ACC) grade on Day 28 | 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye |  | 28 days | 
| Anterior Chamber Cell (ACC) grade on Day 21 | For FDA submission: Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. For submission to EMA related countries: Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye. | 21 days | 
| Change from baseline in ACC Grade on Day 21. |  | 21 days |