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

Last updated: August 23, 2023
Sponsor: Tarsier Pharma
Overall Status: Completed

Phase

3

Condition

Glaucoma

Uveitis

Iritis

Treatment

FDA approved steroid eye drop (masked)

TRS01

Clinical Study ID

NCT05042609
TRS4Vision
  • Ages < 75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At sites in the US: Male or female up to and including 75 years of age (including allpediatric age groups). At sites in the Europe: Male or female between 18 and 70 yearsof 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 anytreatment or with Stable Medical Therapy requiring further treatment.
  • Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eyeusing Early Treatment Diabetic Retinopathy Study (ETDRS).

Exclusion

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 glaucomain 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 abilityto 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.

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: FDA approved steroid eye drop (masked)
Phase: 3
Study Start date:
September 20, 2021
Estimated Completion Date:
June 29, 2023

Connect with a study center

  • Dijon

    Dijon, 21079
    France

    Site Not Available

  • Lyon

    Lyon, 69004
    France

    Site Not Available

  • Nantes

    Nantes, 44000
    France

    Site Not Available

  • Paris

    Paris, 75014
    France

    Site Not Available

  • Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Düsseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Munster

    Munster, 48145
    Germany

    Site Not Available

  • München

    München, 80336
    Germany

    Site Not Available

  • Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • La Jolla

    La Jolla, California 92093
    United States

    Site Not Available

  • Los Angeles

    Los Angeles, California 90041
    United States

    Site Not Available

  • Los Angeles 2

    Los Angeles, California 90095-6984
    United States

    Site Not Available

  • Aurora

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Lakewood

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Jacksonville

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Winter Haven

    Winter Haven, Florida 33800
    United States

    Site Not Available

  • Marietta

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Waltham

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Washington, MO

    Washington, Missouri 63090
    United States

    Site Not Available

  • Palisades Park

    Palisades Park, New Jersey 07650
    United States

    Site Not Available

  • Winston-Salem

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Nashville

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • Plano

    Plano, Texas 75075
    United States

    Site Not Available

  • San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • San Antonio 2

    San Antonio, Texas 78238
    United States

    Site Not Available

  • Norfolk

    Norfolk, Virginia 23502
    United States

    Site Not Available

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