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A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

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ClinicalTrials.gov Identifier: NCT04222712
Recruitment Status : Completed
First Posted : January 10, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Tarsius Pharma

Study Description
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Brief Summary:

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis

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Condition or disease Intervention/treatment Phase
Non-infectious Anterior Uveitis Drug: TRS01 eye drops Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : August 24, 2020
Actual Study Completion Date : August 24, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TRS01 low dose Drug: TRS01 eye drops
Dosed four times a day (QID)
Experimental: TRS01 high dose Drug: TRS01 eye drops
Dosed four times a day (QID)


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of both systemic and ocular adverse events [ Time Frame: 10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222712


Locations
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United States, New Jersey
Palisades Park
Palisades Park, New Jersey, United States, 07650
United States, Texas
San Antonio
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Tarsius Pharma
More Information
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Responsible Party: Tarsius Pharma
ClinicalTrials.gov Identifier: NCT04222712    
Other Study ID Numbers: GADOT 20/20
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
 Panuveitis
Iris Diseases
Ophthalmic Solutions
Pharmaceutical Solutions