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

Launched by TARSUS PHARMACEUTICALS, INC. · Mar 2, 2021

Keywords

ClinConnect Summary

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 primary objective of the study is to assess the safety and efficacy of TP-03, 0.25% compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intrao...

Gender

ALL

Eligibility 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