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

• Status: Completed
• Trial end date: 2021-05-04
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tarsus Pharmaceuticals, Inc.
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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