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A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05042609
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Tarsier Pharma

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

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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 : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

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 :
  1. Anterior Chamber Cell (ACC) grade on Day 28 [ Time Frame: 28 days ]

    In the US, the proportion of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye.

    In Europe, the proportion of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.



Secondary Outcome Measures :
  1. Anterior Chamber Cell (ACC) grade on Day 21 [ Time Frame: 21 days ]
    In the US: Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. In the EU: Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye.

  2. Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye [ Time Frame: 28 days ]
  3. Change from baseline (Day 1) in ACC Grade on Day 21 in the study eye [ Time Frame: 21 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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


Contacts
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Contact: Lexitas Clinical Trials 919-205-0012 clinicaltrials@lexitas.com

Locations
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United States, Florida
Jacksonville Recruiting
Jacksonville, Florida, United States, 32204
Contact: Lexitas Clinical Trials    919-205-0012    clinicaltrials@lexitas.com   
Winter Haven Recruiting
Winter Haven, Florida, United States, 33800
Contact: Lexitas Clinical Trials    919-205-0012    clinicaltrials@lexitas.com   
United States, Georgia
Marietta Recruiting
Marietta, Georgia, United States, 30060
Contact: Lexitas Clinical Trials    919-205-0012    clinicaltrials@lexitas.com   
United States, Massachusetts
Waltham Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Lexitas Clinical Trials    919-205-0012    clinicaltrials@lexitas.com   
United States, New Jersey
Palisades Park Recruiting
Palisades Park, New Jersey, United States, 07650
Contact: Lexitas Clinical Trials    919-205-0012    clinicaltrials@lexitas.com   
United States, Texas
Plano Recruiting
Plano, Texas, United States, 75075
Contact: Lexitas Clinical Trials    919-205-0012    clinicaltrials@lexitas.com   
San Antonio Recruiting
San Antonio, Texas, United States, 78240
Contact: Lexitas Clinical Trials    919-205-0012    clinicaltrials@lexitas.com   
Sponsors and Collaborators
Tarsier Pharma
Investigators
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Study Director: Lexitas Clinical Trials Lexitas
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Responsible Party: Tarsier Pharma
ClinicalTrials.gov Identifier: NCT05042609    
Other Study ID Numbers: TRS4Vision
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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