Clinical trial NCT05042609: A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-infectious Anterior Uveitis
Uveitic Glaucoma
Lead sponsor: Tarsier Pharma
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 142
Sex: ALL
Minimum age (years): 0
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Anterior Chamber Cell (ACC) grade on Day 28
timeFrame: 28 days
Secondary outcomes:
measure: Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye
timeFrame: 28 days
measure: Anterior Chamber Cell (ACC) grade on Day 21
timeFrame: 21 days
measure: Change from baseline in ACC Grade on Day 21.
timeFrame: 21 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: La Jolla
state: California
city: Los Angeles
country: United States
facility: Los Angeles
state: California
city: Los Angeles
country: United States
facility: Los Angeles 2
state: California
city: Aurora
country: United States
facility: Aurora
state: Colorado
city: Lakewood
country: United States
facility: Lakewood
state: Colorado
city: Jacksonville
country: United States
facility: Jacksonville
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven
state: Florida
city: Marietta
country: United States
facility: Marietta
state: Georgia
city: Boston
country: United States
facility: Boston
state: Massachusetts
city: Waltham
country: United States
facility: Waltham
state: Massachusetts
city: Washington
country: United States
facility: Washington, MO
state: Missouri
city: Palisades Park
country: United States
facility: Palisades Park
state: New Jersey
city: Winston-Salem
country: United States
facility: Winston-Salem
state: North Carolina
city: Nashville
country: United States
facility: Nashville
state: Tennessee
city: Austin
country: United States
facility: Austin
state: Texas
city: Plano
country: United States
facility: Plano
state: Texas
city: San Antonio
country: United States
facility: San Antonio 2
state: Texas
city: San Antonio
country: United States
facility: San Antonio
state: Texas
city: Norfolk
country: United States
facility: Norfolk
state: Virginia
city: Dijon
country: France
facility: Dijon
city: Lyon
country: France
facility: Lyon
city: Nantes
country: France
facility: Nantes
city: Paris
country: France
facility: Paris
city: Paris
country: France
facility: Paris
city: Bonn
country: Germany
facility: Bonn
city: Düsseldorf
country: Germany
facility: Düsseldorf
city: Freiburg
country: Germany
facility: Freiburg
city: Munster
country: Germany
facility: Munster
city: München
country: Germany
facility: München
city: Tübingen
country: Germany
facility: Tübingen
Study officials:
affiliation: Lexitas
name: Lexitas Clinical Trials
role: STUDY_DIRECTOR
References: