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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 : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
Tarsier Pharma

Tracking Information
First Submitted Date  ICMJE September 3, 2021
First Posted Date  ICMJE September 13, 2021
Last Update Posted Date December 7, 2022
Actual Study Start Date  ICMJE September 20, 2021
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2022)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2021)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2022)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2021)
  • 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.
  • Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye [ Time Frame: 28 days ]
  • Change from baseline (Day 1) in ACC Grade on Day 21 in the study eye [ Time Frame: 21 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-infectious Anterior Uveitis
  • Uveitic Glaucoma
Intervention  ICMJE
  • Drug: TRS01
    TRS01 eye drops Dosed four times a day (QID)
  • Drug: FDA approved steroid eye drop
    FDA approved steroid eye drop Dosed four times a day (QID)
Study Arms  ICMJE
  • Experimental: TRS01
    Intervention: Drug: TRS01
  • Active Comparator: Active comparator
    Intervention: Drug: FDA approved steroid eye drop
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2021)
162
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 0 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lexitas Clinical Trials 919-205-0012 clinicaltrials@lexitas.com
Listed Location Countries  ICMJE France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05042609
Other Study ID Numbers  ICMJE TRS4Vision
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tarsier Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tarsier Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lexitas Clinical Trials Lexitas
PRS Account Tarsier Pharma
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP