Status:
COMPLETED
Trial to Evaluate the 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:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and efficacy of TP-03, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in hum...
Detailed Description
This Phase 3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03 to vehicle control for the treatment of Demodex blepharitis. The ...
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 used a prostaglandin analogue to promote eyelash growth within 30 days of Screening or any plans to initiate treatment 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
- Be pregnant or lactating at the time of Screening
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT04784091
Start Date
April 29 2021
End Date
May 9 2022
Last Update
December 21 2023
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Global Retina Institute
Scottsdale, Arizona, United States, 85254
2
Shultz Chang Vision
Northridge, California, United States, 91325
3
East Bay Eye Center
San Ramon, California, United States, 94583
4
Vision Institute
Colorado Springs, Colorado, United States, 80907