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

Non-infectious Anterior Uveitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042609
• Other study ID #: TRS4Vision
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2021
• Est. completion date: June 29, 2023

Study information

• Verified date: August 2023
• Source: Tarsier Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Iridocyclitis
• Non-infectious Anterior Uveitis
• Uveitic Glaucoma
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• TRS01
TRS01 eye drops Dosed four times a day (QID)
• FDA approved steroid eye drop (masked)
FDA approved steroid eye drop Dosed four times a day (QID)

Locations

Country	Name	City	State
France	Dijon	Dijon
France	Lyon	Lyon
France	Nantes	Nantes
France	Paris	Paris
France	Paris	Paris
Germany	Bonn	Bonn
Germany	Düsseldorf	Düsseldorf
Germany	Freiburg	Freiburg
Germany	München	München
Germany	Munster	Munster
Germany	Tübingen	Tübingen
United States	Aurora	Aurora	Colorado
United States	Austin	Austin	Texas
United States	Boston	Boston	Massachusetts
United States	Jacksonville	Jacksonville	Florida
United States	La Jolla	La Jolla	California
United States	Lakewood	Lakewood	Colorado
United States	Los Angeles	Los Angeles	California
United States	Los Angeles 2	Los Angeles	California
United States	Marietta	Marietta	Georgia
United States	Nashville	Nashville	Tennessee
United States	Norfolk	Norfolk	Virginia
United States	Palisades Park	Palisades Park	New Jersey
United States	Plano	Plano	Texas
United States	San Antonio	San Antonio	Texas
United States	San Antonio 2	San Antonio	Texas
United States	Waltham	Waltham	Massachusetts
United States	Washington, MO	Washington	Missouri
United States	Winston-Salem	Winston-Salem	North Carolina
United States	Winter Haven	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tarsier Pharma

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye		28 days
Secondary	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
Secondary	Change from baseline in ACC Grade on Day 21.		21 days