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

October 13, 2021 updated by: Tarsier Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Inglewood, California, United States, 90302
        • Inglewood
      • Petaluma, California, United States, 94954
        • Petaluma
    • Missouri
      • Washington, Missouri, United States, 63090
        • Washington, MO
    • New York
      • New York, New York, United States, 10013
        • New York
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo eye drops
Dosed QID
Experimental: TRS01 low dose
Drug: TRS01 eye drops
Dosed 4 times a day (QID)
Drug: TRS01 eye drops
Dosed QID
Experimental: TRS01 high dose
Drug: TRS01 eye drops
Dosed 4 times a day (QID)
Drug: TRS01 eye drops
Dosed QID
Experimental: TRS01 medium dose
Drug: TRS01 eye drops
Dosed 4 times a day (QID)
Drug: TRS01 eye drops
Dosed QID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Both Systemic and Ocular Adverse Events
Time Frame: 14 days
Number of adverse events that occurred during the study
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsier Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

July 17, 2020

Study Completion (Actual)

July 17, 2020

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tarsius 2020
  • 2019-004327-20 (EudraCT Number)
  • Grant Agreement Number 879598 (Other Grant/Funding Number: European Union's Horizon 2020)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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