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

Phase 3

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Active comparator	FDA approved steroid eye drop (masked)	-
TRS01	TRS01	-

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Cell (ACC) grade on Day 28	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.

Secondary Outcome Measures

Name	Time	Method
Anterior Chamber Cell (ACC) grade on Day 21	21 days	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.
Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye	28 days
Change from baseline in ACC Grade on Day 21.	21 days

Locations (29): Los Angeles 2
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Los Angeles, California, United States
Boston
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Boston, Massachusetts, United States
Paris
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Paris, France
Aurora
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Aurora, Colorado, United States
Lakewood
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Lakewood, Colorado, United States
Nashville
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Nashville, Tennessee, United States
Waltham
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Waltham, Massachusetts, United States
Palisades Park
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Palisades Park, New Jersey, United States
Munster
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Munster, Germany
La Jolla
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La Jolla, California, United States
Los Angeles
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Los Angeles, California, United States
Jacksonville
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Jacksonville, Florida, United States
Marietta
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Marietta, Georgia, United States
Winter Haven
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Winter Haven, Florida, United States
Washington, MO
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Washington, Missouri, United States
Winston-Salem
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Winston-Salem, North Carolina, United States
Plano
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Plano, Texas, United States
Austin
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Austin, Texas, United States
San Antonio 2
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San Antonio, Texas, United States
San Antonio
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San Antonio, Texas, United States
Norfolk
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Norfolk, Virginia, United States
Dijon
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Dijon, France
Lyon
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Lyon, France
Nantes
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Nantes, France
Bonn
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Bonn, Germany
Freiburg
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Freiburg, Germany
Düsseldorf
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Düsseldorf, Germany
München
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München, Germany
Tübingen
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Tübingen, Germany