Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

Completed · Phase 2/Phase 3

Conditions studied: Blepharitis

In brief

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 in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.

Key facts

Study ID

NCT04475432

Run by

Tarsus Pharmaceuticals, Inc.

People needed

421

Starts

2020-09-09

Expected to finish

2021-05-04

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
• Eye Research Foundation — Newport Beach, California, United States
• Visionary Eye Institute — Newport Beach, California, United States
• Vision Institute — Colorado Springs, Colorado, United States
• Midwest Cornea Associates, LLC — Carmel, Indiana, United States
• Washburn Research LLC — Indianapolis, Indiana, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Oculus Research, Inc at EyecareCenter — Raleigh, North Carolina, United States
• Vita Eye Clinic — Shelby, North Carolina, United States
• Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
• Total Eye Care, P.A. — Memphis, Tennessee, United States
• Alpine Research Organization — Layton, Utah, United States
• Piedmont Eye Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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