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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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 human hair follicles.

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

Details

• Lead Sponsor: Tarsus Pharmaceuticals, Inc.

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 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