Skip to main content
OpenTrials
Completed

NCT Number: NCT05042609

A Study of TRS01 in 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-infectious Anterior Uveitis Uveitic Glaucoma

Age range

0 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dijon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRS01

Drug

TRS01 eye drops Dosed four times a day (QID)

FDA approved steroid eye drop (masked)

Drug

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

Primary outcomes

  1. Anterior Chamber Cell (ACC) Grade = 0 on Day 28

    Time frame: 28 days

    For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye.

    ACC=0 is complete resolution of inflammation (0 cells).

  2. Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28

    Time frame: 28 days

    For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.

    ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.

Secondary outcomes

  1. Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye

    Time frame: 28 days

    Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation).

    ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level

    Change from baseline measures the mean change in ACC grade on Day 28 in the study eye

  2. Anterior Chamber Cell (ACC) Grade on Day 21

    Time frame: 21 days

    Proportion of subjects with ACC Grade=0 on Day 21 in the study eye.

  3. Change From Baseline in ACC Grade on Day 21.

    Time frame: 21 days

    Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation).

    ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 21 in the study eye

  4. Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21

    Time frame: 21 days

    Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.

Sponsors and collaborators

Lead sponsor

Tarsier Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.