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

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