Phase 3
N=139
A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
Non-infectious Anterior Uveitis · Uveitic Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT05042609 ↗Enrolled (actual)
139
Serious AEs
1.4%
Results posted
May 2026
Primary outcome: Primary: Anterior Chamber Cell (ACC) Grade = 0 on Day 28 — 38; 32; 44; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TRS01 (Drug); FDA approved steroid eye drop (masked) (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Tarsier Pharma
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Chamber Cell (ACC) Grade = 0 on Day 28 |
38; 32; 44; 15 | — |
| PRIMARY Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28 |
52; 42 | — |
| SECONDARY Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye |
-1.9; -2.2 | — |
| SECONDARY Anterior Chamber Cell (ACC) Grade on Day 21 |
32; 29 | — |
| SECONDARY Change From Baseline in ACC Grade on Day 21. |
-1.7; -2.1 | — |
| SECONDARY Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21 |
50; 40 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05042609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.