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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-infectious Anterior Uveitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Palisades Park, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRS01 eye drops

Drug

Dosed four times a day (QID)

Primary outcomes

Assessment of Both Systemic and Ocular Adverse Events

Time frame: 10 weeks

Number of patients experiencing Adverse Events during the study

Sponsors and collaborators

Lead sponsor

Tarsier Pharma

Industry

Registry information

Official study title

A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jan 10, 2020
Registry last updated: Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed