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

Completed · Phase 3

Conditions studied: Blepharitis

In brief

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.

Key facts

Study ID

NCT04784091

Run by

Tarsus Pharmaceuticals, Inc.

People needed

412

Starts

2021-04-29

Expected to finish

2022-05-09

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 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

Where it is running

• Global Retina Institute — Scottsdale, Arizona, United States
• Shultz Chang Vision — Northridge, California, United States
• East Bay Eye Center — San Ramon, California, United States
• Vision Institute — Colorado Springs, Colorado, United States
• Pinnacle Research Institute — Fort Lauderdale, Florida, United States
• Jackson Eye, S.C. — Lake Villa, Illinois, United States
• Pankratz Eye Institute — Columbus, Indiana, United States
• Michael Washburn Center for Ophthalmic Research LLC — Indianapolis, Indiana, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Complete Eye Care of Medina — Medina, Minnesota, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• NC Eye Associates — Apex, North Carolina, United States
• Pure Ophthalmic Research — Mint Hill, North Carolina, United States
• Vita Eye Clinic — Shelby, North Carolina, United States
• Northern Ophthalmic Associates — Jenkintown, Pennsylvania, United States
• Alpine Research Organization / Healthy Heart Clinics of America — Clinton, Utah, United States
• Alpine Research Organization Inc./ Country Hills Eye Center — Ogden, Utah, United States
• Periman Eye Institute — Seattle, Washington, United States
• New River Vision Care — Oak Hill, West Virginia, United States

Full record on ClinicalTrials.gov

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