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A Study of TRS01 in Participants With Post-surgical Ocular Inflammation

Primary Purpose

Post Surgical Ocular Inflammation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TRS01 eye drops

Placebo eye drops

About this trial

This is an interventional treatment trial for Post Surgical Ocular Inflammation focused on measuring postoperative, postsurgical, ocular, inflammation, pain

Eligibility Criteria

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

Inclusion Criteria:

Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:

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
Randomization inclusion criteria as specified per protocol.

Exclusion Criteria:

Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
Receiving specific medication/interventions as specified per protocol

Sites / Locations

Inglewood
Petaluma
Washington, MO
New York
Cincinnati

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

TRS01 low dose

TRS01 medium dose

TRS01 high dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Assessment of Both Systemic and Ocular Adverse Events

Number of adverse events that occurred during the study

Secondary Outcome Measures

Full Information

NCT ID

NCT04222725

First Posted

January 7, 2020

Last Updated

October 13, 2021

Sponsor

Tarsier Pharma

1. Study Identification

Unique Protocol Identification Number

NCT04222725

Brief Title

A Study of TRS01 in Participants With Post-surgical Ocular Inflammation

Official Title

A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

July 17, 2020 (Actual)

Study Completion Date

July 17, 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 and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Surgical Ocular Inflammation

Keywords

postoperative, postsurgical, ocular, inflammation, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRS01 low dose

Arm Type

Experimental

Arm Title

TRS01 medium dose

Arm Type

Experimental

Arm Title

TRS01 high dose

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TRS01 eye drops

Intervention Description

Dosed 4 times a day (QID)

Intervention Type

Drug

Intervention Name(s)

TRS01 eye drops

Intervention Description

Dosed QID

Intervention Type

Drug

Intervention Name(s)

TRS01 eye drops

Intervention Description

Dosed QID

Intervention Type

Drug

Intervention Name(s)

Placebo eye drops

Intervention Description

Dosed QID

Primary Outcome Measure Information:

Title

Assessment of Both Systemic and Ocular Adverse Events

Description

Number of adverse events that occurred during the study

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are: 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 Randomization inclusion criteria as specified per protocol. Exclusion Criteria: Scheduled to undergo cataract surgery in the non-study eye for the duration of the study. Receiving specific medication/interventions as specified per protocol

Facility Information:

Facility Name

Inglewood

City

Inglewood

State/Province

California

ZIP/Postal Code

90302

Country

United States

Facility Name

Petaluma

City

Petaluma

State/Province

California

ZIP/Postal Code

94954

Country

United States

Facility Name

Washington, MO

City

Washington

State/Province

Missouri

ZIP/Postal Code

63090

Country

United States

Facility Name

New York

City

New York

State/Province

New York

ZIP/Postal Code

10013

Country

United States

Facility Name

Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of TRS01 in Participants With Post-surgical Ocular Inflammation

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