A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Primary Purpose
Non-infectious Anterior Uveitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TRS01 eye drops
TRS01 eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Non-infectious Anterior Uveitis
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
- Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.
An eligible subject must have:
- Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
- Must have vision ≥ 20/40 in the non-study eye.
- Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.
Exclusion Criteria:
- Any form of infectious uveitis
- Active retinitis
- Cancer or melanoma that is actively treated with immunotherapy
- Pregnancy / lactation
- Receiving specific medication/interventions as specified per protocol
Sites / Locations
- Palisades Park
- San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TRS01 low dose
TRS01 high dose
Arm Description
Outcomes
Primary Outcome Measures
Assessment of Both Systemic and Ocular Adverse Events
Number of patients experiencing Adverse Events during the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04222712
Brief Title
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Official Title
A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 24, 2020 (Actual)
Study Completion Date
August 24, 2020 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-infectious Anterior Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRS01 low dose
Arm Type
Experimental
Arm Title
TRS01 high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TRS01 eye drops
Intervention Description
Dosed four times a day (QID)
Intervention Type
Drug
Intervention Name(s)
TRS01 eye drops
Intervention Description
Dosed four times a day (QID)
Primary Outcome Measure Information:
Title
Assessment of Both Systemic and Ocular Adverse Events
Description
Number of patients experiencing Adverse Events during the study
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.
An eligible subject must have:
Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
Must have vision ≥ 20/40 in the non-study eye.
Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.
Exclusion Criteria:
Any form of infectious uveitis
Active retinitis
Cancer or melanoma that is actively treated with immunotherapy
Pregnancy / lactation
Receiving specific medication/interventions as specified per protocol
Facility Information:
Facility Name
Palisades Park
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Facility Name
San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
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