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

Phase 3

Completed

• Conditions: Uveitic Glaucoma; Non-infectious Anterior Uveitis
• Interventions: Drug: FDA approved steroid eye drop (masked); Drug: TRS01

• Registration Number: NCT05042609
• Lead Sponsor: Tarsier Pharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Study Start: 2021-09-20
• Primary Completion: 2023-06-29
• Study Completion: 2023-06-29
• Disposition First Submitted: 2023-07-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Disposition First Posted: 2023-08-28
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active comparator	FDA approved steroid eye drop (masked)	-
TRS01	TRS01	-

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Cell (ACC) grade on Day 28	28 days	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in ACC Grade on Day 21.	21 days
Anterior Chamber Cell (ACC) grade on Day 21	21 days	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.
Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye	28 days

Trial Locations

Locations (29)

La Jolla; 🇺🇸 La Jolla, California, United States

Los Angeles; 🇺🇸 Los Angeles, California, United States

Los Angeles 2; 🇺🇸 Los Angeles, California, United States

Aurora; 🇺🇸 Aurora, Colorado, United States

Lakewood; 🇺🇸 Lakewood, Colorado, United States

Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Winter Haven; 🇺🇸 Winter Haven, Florida, United States

Marietta; 🇺🇸 Marietta, Georgia, United States

Boston; 🇺🇸 Boston, Massachusetts, United States

Waltham; 🇺🇸 Waltham, Massachusetts, United States

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