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

NCT05042609 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: TRS4Vision
• Study Type: interventional
• Target: 142
• Locations: 3 countries
• Sites: 30

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

Conditions

Non-infectious Anterior Uveitis; Uveitic Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  21 days

• Change from baseline in ACC Grade on Day 21.

  21 days

Study Arms (2)

TRS01

EXPERIMENTAL

Drug: TRS01

Active comparator

ACTIVE COMPARATOR

Drug: FDA approved steroid eye drop (masked)

Interventions

TRS01 DRUG

TRS01 eye drops Dosed four times a day (QID)

TRS01

FDA approved steroid eye drop (masked) DRUG

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

Active comparator

Eligibility Criteria

• Age: 0 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarsier Pharma: lead

Study Sites (30)

La Jolla

La Jolla, California, 92093, United States

Location

Los Angeles

Los Angeles, California, 90041, United States

Location

Los Angeles 2

Los Angeles, California, 90095-6984, United States

Location

Aurora

Aurora, Colorado, 80045, United States

Location

Lakewood

Lakewood, Colorado, 80228, United States

Location

Jacksonville

Jacksonville, Florida, 32204, United States

Location

Winter Haven

Winter Haven, Florida, 33800, United States

Location

Marietta

Marietta, Georgia, 30060, United States

Location

Boston

Boston, Massachusetts, 02114, United States

Location

Waltham

Waltham, Massachusetts, 02451, United States

Location

Washington, MO

Washington, Missouri, 63090, United States

Location

Palisades Park

Palisades Park, New Jersey, 07650, United States

Location

Winston-Salem

Winston-Salem, North Carolina, 27157, United States

Location

Nashville

Nashville, Tennessee, 37232, United States

Location

Austin

Austin, Texas, 78712, United States

Location

Plano

Plano, Texas, 75075, United States

Location

San Antonio 2

San Antonio, Texas, 78238, United States

Location

San Antonio

San Antonio, Texas, 78240, United States

Location

Norfolk

Norfolk, Virginia, 23502, United States

Location

Dijon

Dijon, 21079, France

Location

Lyon

Lyon, 69004, France

Location

Nantes

Nantes, 44000, France

Location

Paris

Paris, 75013, France

Location

Paris

Paris, 75014, France

Location

Bonn

Bonn, 53127, Germany

Location

Düsseldorf

Düsseldorf, 40225, Germany

Location

Freiburg

Freiburg im Breisgau, 79106, Germany

Location

München

München, 80336, Germany

Location

Munster

Münster, 48145, Germany

Location

Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Lexitas Clinical Trials

  Lexitas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: September 20, 2021
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); DE (6); FR (5)