Summary

Eligibility
for people ages up to 70 years (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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

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

Keywords

Non-infectious Anterior Uveitis Uveitic Glaucoma Glaucoma Uveitis Uveitis, Anterior Iridocyclitis Ophthalmic Solutions TRS01 FDA approved steroid eye drop

Eligibility

You can join if…

Open to people ages up to 70 years

  • At sites in the US: Male or female up to and including 70 years of age (including all pediatric age groups). At sites in the EU: 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).

You CAN'T join if...

  • 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.

Locations

  • Los Angeles 2 accepting new patients
    Los Angeles California 90095-6984 United States
  • La Jolla accepting new patients
    La Jolla California 92093 United States
  • Los Angeles accepting new patients
    Los Angeles California 90041 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tarsier Pharma
ID
NCT05042609
Phase
Phase 3 Research Study
Study Type
Interventional
Participants
Expecting 162 study participants
Last Updated