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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 13, 2021
Last Update Posted : April 18, 2023
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Sponsor:
Tarsier Pharma
Information provided by (Responsible Party):
Tarsier Pharma
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Brief 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
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Early-onset glaucoma
MedlinePlus related topics:
Glaucoma
| Arm | Intervention/treatment |
|---|---|
| Experimental: TRS01 |
Drug: TRS01
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) |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 0 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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).
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.
Information from the National Library of Medicine
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
Locations
Show 30 study locations
Sponsors and Collaborators
Tarsier Pharma
Investigators
| Study Director: | Lexitas Clinical Trials | Lexitas |
| Responsible Party: | Tarsier Pharma |
| ClinicalTrials.gov Identifier: | NCT05042609 |
| Other Study ID Numbers: |
TRS4Vision |
| First Posted: | September 13, 2021 Key Record Dates |
| Last Update Posted: | April 18, 2023 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Glaucoma Uveitis Uveitis, Anterior Iridocyclitis Ocular Hypertension Eye Diseases |
Uveal Diseases Panuveitis Iris Diseases Ophthalmic Solutions Pharmaceutical Solutions |