NCT04475432

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

Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Tarsus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.

Detailed description

This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, 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 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 and dilated ophthalmoscopy findings.

Conditions

• Blepharitis

Interventions

Type	Name	Description
DRUG	TP-03, 0.25%	TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
DRUG	TP-03 Vehicle	Vehicle of TP-03 ophthalmic solution, administered twice a day

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2020-07-17
• Last updated: 2023-12-21
• Results posted: 2023-12-21

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study