Status:
COMPLETED
Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Lead Sponsor:
Tarsus Pharmaceuticals, Inc.
Conditions:
Blepharitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found...
Detailed Description
This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepha...
Eligibility Criteria
Inclusion
- Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash
Exclusion
- Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
- Have worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear during the study
- Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
- Pregnancy or lactation
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
421 Patients enrolled
Trial Details
Trial ID
NCT04475432
Start Date
September 9 2020
End Date
May 4 2021
Last Update
December 21 2023
Active Locations (15)
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1
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
2
Eye Research Foundation
Newport Beach, California, United States, 92663
3
Visionary Eye Institute
Newport Beach, California, United States, 92663
4
Vision Institute
Colorado Springs, Colorado, United States, 80907