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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

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

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

NCT ID

NCT04222712

First Posted

January 7, 2020

Last Updated

October 4, 2023

Sponsor

Tarsier Pharma

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

Data Monitoring Committee

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

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

Learn more about this trial

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

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