A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
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|ClinicalTrials.gov Identifier: NCT05042609|
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : June 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non-infectious Anterior Uveitis Uveitic Glaucoma||Drug: TRS01 Drug: FDA approved steroid eye drop||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 20, 2021|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
TRS01 eye drops Dosed four times a day (QID)
|Active Comparator: Active comparator||
Drug: FDA approved steroid eye drop
FDA approved steroid eye drop Dosed four times a day (QID)
- Anterior Chamber Cell (ACC) grade on Day 28 [ Time Frame: 28 days ]
For FDA submission: the proportion of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye.
For submission to European Medicines Agency (EMA) related countries: the proportion of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.
- Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye [ Time Frame: 28 days ]
- Anterior Chamber Cell (ACC) grade on Day 21 [ Time Frame: 21 days ]
For FDA submission: Proportion of subjects with ACC Grade=0 on Day 21 in the study eye.
For submission to EMA related countries: Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye.
- Change from baseline in ACC Grade on Day 21. [ Time Frame: 21 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05042609
|Contact: Lexitas Clinical Trialsfirstname.lastname@example.org|
|Study Director:||Lexitas Clinical Trials||Lexitas|