A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
NCT ID: NCT04222725
Last Updated: 2021-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
37 participants
INTERVENTIONAL
2020-02-01
2020-07-17
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 4 times a day (QID)
TRS01 medium dose
TRS01 eye drops
Dosed QID
TRS01 high dose
TRS01 eye drops
Dosed QID
Placebo
Placebo eye drops
Dosed QID
Interventions
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TRS01 eye drops
Dosed 4 times a day (QID)
TRS01 eye drops
Dosed QID
TRS01 eye drops
Dosed QID
Placebo eye drops
Dosed QID
Eligibility Criteria
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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.
* Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery.
* Have vision ≥ 20/200 in the non-study eye.
* Able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops.
* Have no known sensitivity /allergy to the TRS01 or formulation excipients.
* Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol
Exclusion Criteria
* 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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Inglewood
Inglewood, California, United States
Petaluma
Petaluma, California, United States
Washington, MO
Washington, Missouri, United States
New York
New York, New York, United States
Cincinnati
Cincinnati, Ohio, 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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2019-004327-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Grant Agreement Number 879598
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Tarsius 2020
Identifier Type: -
Identifier Source: org_study_id