NCT06182358

Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers

Randomized Controlled Trial to Evaluate the Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Tarsus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of XDEMVY ophthalmic drop to its vehicle control for the treatment of Demodex blepharitis and its impact on the soft contact lens wearing experience.

Detailed description

This Phase 4 study is a prospective, multicenter, randomized, vehicle-controlled, double-masked, two-arm, parallel treatment clinical trial of participants who have Demodex blepharitis and are current daily wear soft contact lenses wearers. The primary outcome measure is the reduction of collarettes at Day 43. The secondary outcome measures are the reduction of eyelid margin erythema at Day 43; subject-reported comfortable contact lens daily wear time; and total contact lens wear time. Safety will be determined by assessing adverse effects related to study drug administration as well as evaluating any clinically significant changes from baseline in visual acuity and slit lamp biomicroscopy findings.

Conditions

• Demodex Blepharitis

Interventions

Type	Name	Description
DRUG	Lotilaner ophthalmic solution, 0.25%	XDEMVY (lotilaner ophthalmic solution) 0.25%, administered topically twice a day for approximately 43 days
DRUG	Vehicle control	Vehicle of XDEMVY administered topically twice a day for approximately 43 days

Timeline

• Start date: 2023-12-27
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2023-12-26
• Last updated: 2025-07-02

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study