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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
TRS01 eye drops
TRS01 eye drops
Placebo eye drops
Sponsored by
Tarsier Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

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

First Posted
January 7, 2020
Last Updated
October 13, 2021
Sponsor
Tarsier Pharma
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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
No
Data Monitoring Committee
No

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
No
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
No

Learn more about this trial

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

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