Phase 2 N=16 Randomized Quadruple-blind Treatment

A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

Non-infectious Anterior Uveitis

Bottom Line

View on ClinicalTrials.gov: NCT04222712 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Assessment of Both Systemic and Ocular Adverse Events — 2; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: TRS01 eye drops (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tarsier Pharma
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Both Systemic and Ocular Adverse Events	2; 5	—

Summary

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis .

Eligibility Criteria

Inclusion Criteria

18 years of age or older
Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.

An eligible subject must have:

Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
Must have vision ≥ 20/40 in the non-study eye.
Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.

Exclusion Criteria

Any form of infectious uveitis
Active retinitis
Cancer or melanoma that is actively treated with immunotherapy
Pregnancy / lactation
Receiving specific medication/interventions as specified per protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04222712). 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.