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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
Tarsier Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-infectious Anterior Uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 7, 2020
Last Updated
October 4, 2023
Sponsor
Tarsier Pharma
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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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