← Back to all trials
Completed
NCT05042609
TRS4Vision - A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
Conditions: Non-infectious Anterior Uveitis, Uveitic Glaucoma
Sex: All
Ages: 0 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 142
Sponsor: Tarsier Pharma
Location: La Jolla La Jolla California
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.
Source: ClinicalTrials.gov (NCT05042609). StuddyBuddy aggregates publicly available trial information.