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

NCT06182358 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

  • Demodex Blepharitis

Interventions

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

Sponsors & Collaborators

  • Tarsus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Blake Simmons, OD · Vision Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2025-01-27
Completion
2025-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06182358 on ClinicalTrials.gov