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

A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

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

Study Overview

• Status: Completed
• Conditions: Uveitic Glaucoma; Non-infectious Anterior Uveitis
• Intervention / Treatment: Drug: TRS01; Drug: FDA approved steroid eye drop (masked)

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lexitas Clinical Trials; Phone Number: 919-205-0012; Email: clinicaltrials@lexitas.com

Study Locations

• France
  • Dijon, France, 21079
    • Dijon
  • Lyon, France, 69004
    • Lyon
  • Nantes, France, 44000
    • Nantes
  • Paris, France, 75013
    • Paris
  • Paris, France, 75014
    • Paris
• Germany
  • Bonn, Germany, 53127
    • Bonn
  • Düsseldorf, Germany, 40225
    • Düsseldorf
  • Freiburg, Germany, 79106
    • Freiburg
  • Munster, Germany, 48145
    • Munster
  • München, Germany, 80336
    • München
  • Tübingen, Germany, 72076
    • Tübingen
• United States
  • California
    • La Jolla, California, United States, 92093
      • La Jolla
    • Los Angeles, California, United States, 90041
      • Los Angeles
    • Los Angeles, California, United States, 90095-6984
      • Los Angeles 2
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Aurora
    • Lakewood, Colorado, United States, 80228
      • Lakewood
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Jacksonville
    • Winter Haven, Florida, United States, 33800
      • Winter Haven
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Boston
    • Waltham, Massachusetts, United States, 02451
      • Waltham
  • Missouri
    • Washington, Missouri, United States, 63090
      • Washington, MO
  • New Jersey
    • Palisades Park, New Jersey, United States, 07650
      • Palisades Park
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Winston-Salem
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Nashville
  • Texas
    • Austin, Texas, United States, 78712
      • Austin
    • Plano, Texas, United States, 75075
      • Plano
    • San Antonio, Texas, United States, 78240
      • San Antonio
    • San Antonio, Texas, United States, 78238
      • San Antonio 2
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Norfolk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRS01	Drug: TRS01; TRS01 eye drops Dosed four times a day (QID)
Active Comparator: Active comparator	Drug: FDA approved steroid eye drop (masked); FDA approved steroid eye drop Dosed four times a day (QID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	21 days
Change from baseline in ACC Grade on Day 21.		21 days

Collaborators and Investigators

• Sponsor: Tarsier Pharma
• Investigators: Study Director: Lexitas Clinical Trials, Lexitas

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Panuveitis; Uveal Diseases; Iris Diseases; Glaucoma; Uveitis; Uveitis, Anterior; Iridocyclitis; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: TRS4Vision

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No