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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2023-06-29

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

Detailed Description

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Conditions

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Non-infectious Anterior Uveitis Uveitic Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TRS01

Group Type EXPERIMENTAL

TRS01

Intervention Type DRUG

TRS01 eye drops Dosed four times a day (QID)

Active comparator

Group Type ACTIVE_COMPARATOR

FDA approved steroid eye drop (masked)

Intervention Type DRUG

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)

Intervention Type DRUG

FDA approved steroid eye drop (masked)

FDA approved steroid eye drop Dosed four times a day (QID)

Intervention Type DRUG

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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tarsier Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Los Angeles

Los Angeles, California, United States

Site Status

Los Angeles 2

Los Angeles, California, United States

Site Status

Aurora

Aurora, Colorado, United States

Site Status

Lakewood

Lakewood, Colorado, United States

Site Status

Jacksonville

Jacksonville, Florida, United States

Site Status

Winter Haven

Winter Haven, Florida, United States

Site Status

Marietta

Marietta, Georgia, United States

Site Status

Boston

Boston, Massachusetts, United States

Site Status

Waltham

Waltham, Massachusetts, United States

Site Status

Washington, MO

Washington, Missouri, United States

Site Status

Palisades Park

Palisades Park, New Jersey, United States

Site Status

Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

Nashville

Nashville, Tennessee, United States

Site Status

Austin

Austin, Texas, United States

Site Status

Plano

Plano, Texas, United States

Site Status

San Antonio 2

San Antonio, Texas, United States

Site Status

San Antonio

San Antonio, Texas, United States

Site Status

Norfolk

Norfolk, Virginia, United States

Site Status

Dijon

Dijon, , France

Site Status

Lyon

Lyon, , France

Site Status

Nantes

Nantes, , France

Site Status

Paris

Paris, , France

Site Status

Paris

Paris, , France

Site Status

Bonn

Bonn, , Germany

Site Status

Düsseldorf

Düsseldorf, , Germany

Site Status

Freiburg

Freiburg im Breisgau, , Germany

Site Status

München

München, , Germany

Site Status

Munster

Münster, , Germany

Site Status

Tübingen

Tübingen, , Germany

Site Status

Countries

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United States France Germany

Other Identifiers

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TRS4Vision

Identifier Type: -

Identifier Source: org_study_id

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