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

Phase 3 Completed 412 enrolled Tarsus Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-04-29
Primary completion: 2022-05-09
Completion: 2022-05-09

Outcome

Met primary endpoint

paper met the primary end point and all secondary end points for the treatment of Demodex blepharitis compared with vehicle control. PMID 37285925 ↗

Publications

Gaddie IB, Donnenfeld ED, Karpecki P, Vollmer P, Berdy GJ, Peterson JD, Simmons B, Edell ARP, Whitson WE, Ciolino JB, Baba SN, Holdbrook M, Trevejo J, Meyer J, Yeu E; Saturn-2 Study Group. Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2). Ophthalmology. 2023 Oct;130(10):1015-1023. doi: 10.1016/j.ophtha.2023.05.030. Epub 2023 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TP-03	Unknown	0.25 %	Topical