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Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis — Saturn-2  

Blepharitis Clinical Trial

Official title:
Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

Clinical Trial 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.

Clinical Trial Description

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, intraocular pressure, slit lamp biomicroscopy, endothelial cell density, hematology, blood chemistry, and urinalysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04784091
Study type Interventional
Source Tarsus Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date April 29, 2021
Completion date May 9, 2022
View Details
See also
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