A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
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.
1 other identifier
interventional
16
1 country
2
Brief Summary
The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2020
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 10, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2020
CompletedResults Posted
Study results publicly available
October 5, 2023
CompletedOctober 5, 2023
August 1, 2023
7 months
January 7, 2020
August 16, 2023
October 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of Both Systemic and Ocular Adverse Events
Number of patients experiencing Adverse Events during the study
10 weeks
Study Arms (2)
TRS01 low dose
EXPERIMENTALTRS01 high dose
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tarsier Pharmalead
Study Sites (2)
Palisades Park
Palisades Park, New Jersey, 07650, United States
San Antonio
San Antonio, Texas, 78240, United States
Results Point of Contact
- Title
- COO
- Organization
- Tarsier Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 10, 2020
Study Start
February 1, 2020
Primary Completion
August 24, 2020
Study Completion
August 24, 2020
Last Updated
October 5, 2023
Results First Posted
October 5, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share