A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
NCT ID: NCT05042609
Last Updated: 2023-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
142 participants
INTERVENTIONAL
2021-09-20
2023-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TRS01
TRS01
TRS01 eye drops Dosed four times a day (QID)
Active comparator
FDA approved steroid eye drop (masked)
FDA approved steroid eye drop Dosed four times a day (QID)
Interventions
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TRS01
TRS01 eye drops Dosed four times a day (QID)
FDA approved steroid eye drop (masked)
FDA approved steroid eye drop Dosed four times a day (QID)
Eligibility Criteria
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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
* 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.
0 Years
75 Years
ALL
No
Sponsors
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Tarsier Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Lexitas Clinical Trials
Role: STUDY_DIRECTOR
Lexitas
Locations
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La Jolla
La Jolla, California, United States
Los Angeles
Los Angeles, California, United States
Los Angeles 2
Los Angeles, California, United States
Aurora
Aurora, Colorado, United States
Lakewood
Lakewood, Colorado, United States
Jacksonville
Jacksonville, Florida, United States
Winter Haven
Winter Haven, Florida, United States
Marietta
Marietta, Georgia, United States
Boston
Boston, Massachusetts, United States
Waltham
Waltham, Massachusetts, United States
Washington, MO
Washington, Missouri, United States
Palisades Park
Palisades Park, New Jersey, United States
Winston-Salem
Winston-Salem, North Carolina, United States
Nashville
Nashville, Tennessee, United States
Austin
Austin, Texas, United States
Plano
Plano, Texas, United States
San Antonio 2
San Antonio, Texas, United States
San Antonio
San Antonio, Texas, United States
Norfolk
Norfolk, Virginia, United States
Dijon
Dijon, , France
Lyon
Lyon, , France
Nantes
Nantes, , France
Paris
Paris, , France
Paris
Paris, , France
Bonn
Bonn, , Germany
Düsseldorf
Düsseldorf, , Germany
Freiburg
Freiburg im Breisgau, , Germany
München
München, , Germany
Munster
Münster, , Germany
Tübingen
Tübingen, , Germany
Countries
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Other Identifiers
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TRS4Vision
Identifier Type: -
Identifier Source: org_study_id
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