A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
NCT ID: NCT04222712
Last Updated: 2023-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
16 participants
INTERVENTIONAL
2020-02-01
2020-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TRS01 low dose
TRS01 eye drops
Dosed four times a day (QID)
TRS01 high dose
TRS01 eye drops
Dosed four times a day (QID)
Interventions
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TRS01 eye drops
Dosed four times a day (QID)
TRS01 eye drops
Dosed four times a day (QID)
Eligibility Criteria
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Inclusion Criteria
* 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
* Active retinitis
* Cancer or melanoma that is actively treated with immunotherapy
* Pregnancy / lactation
* Receiving specific medication/interventions as specified per protocol
18 Years
ALL
No
Sponsors
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Tarsier Pharma
INDUSTRY
Responsible Party
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Locations
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Palisades Park
Palisades Park, New Jersey, United States
San Antonio
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GADOT 20/20
Identifier Type: -
Identifier Source: org_study_id
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