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

Primary Purpose

Non-infectious Anterior Uveitis, Uveitic Glaucoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TRS01
FDA approved steroid eye drop (masked)
Sponsored by
Tarsier Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-infectious Anterior Uveitis

Eligibility Criteria

0 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • La Jolla
  • Los Angeles
  • Los Angeles 2
  • Aurora
  • Lakewood
  • Jacksonville
  • Winter Haven
  • Marietta
  • Boston
  • Waltham
  • Washington, MO
  • Palisades Park
  • Winston-Salem
  • Nashville
  • Austin
  • Plano
  • San Antonio 2
  • San Antonio
  • Norfolk
  • Dijon
  • Lyon
  • Nantes
  • Paris
  • Paris
  • Bonn
  • Düsseldorf
  • Freiburg
  • Munster
  • München
  • Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRS01

Active comparator

Arm Description

Outcomes

Primary Outcome Measures

Anterior Chamber Cell (ACC) grade on Day 28
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
Anterior Chamber Cell (ACC) grade on Day 21
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.

Full Information

First Posted
September 3, 2021
Last Updated
August 23, 2023
Sponsor
Tarsier Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05042609
Brief Title
A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
June 29, 2023 (Actual)
Study Completion Date
June 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tarsier Pharma

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-infectious Anterior Uveitis, Uveitic Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRS01
Arm Type
Experimental
Arm Title
Active comparator
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TRS01
Intervention Description
TRS01 eye drops Dosed four times a day (QID)
Intervention Type
Drug
Intervention Name(s)
FDA approved steroid eye drop (masked)
Intervention Description
FDA approved steroid eye drop Dosed four times a day (QID)
Primary Outcome Measure Information:
Title
Anterior Chamber Cell (ACC) grade on Day 28
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye
Time Frame
28 days
Title
Anterior Chamber Cell (ACC) grade on Day 21
Description
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.
Time Frame
21 days
Title
Change from baseline in ACC Grade on Day 21.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 Europe: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lexitas Clinical Trials
Organizational Affiliation
Lexitas
Official's Role
Study Director
Facility Information:
Facility Name
La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90041
Country
United States
Facility Name
Los Angeles 2
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6984
Country
United States
Facility Name
Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lakewood
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Winter Haven
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33800
Country
United States
Facility Name
Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Waltham
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Washington, MO
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Palisades Park
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Facility Name
Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
San Antonio 2
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Paris
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Paris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Munster
City
Munster
ZIP/Postal Code
48145
Country
Germany
Facility Name
München
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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