Effect of XDEMVY® on eyelid condition in contact lens users

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

This study is testing if XDEMVY eye drops can help contact lens users with a specific eyelid condition called Demodex blepharitis feel better and reduce symptoms after 43 days.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tarsus Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 14 sites (Cave Creek, Arizona and 13 other locations)
• Trial ID: NCT06182358 on ClinicalTrials.gov

What this trial studies

This Phase 4 clinical trial evaluates the effectiveness of XDEMVY ophthalmic drops compared to a vehicle control in treating Demodex blepharitis among individuals who wear soft contact lenses. The study is designed as a multicenter, randomized, double-masked trial, focusing on participants with specific eyelid conditions. Primary outcomes include the reduction of collarettes on the eyelids after 43 days, while secondary outcomes assess eyelid erythema and the comfort of contact lens wear. Safety assessments will monitor any adverse effects and changes in visual acuity.

Who should consider this trial

Good fit: Ideal candidates are individuals who wear soft contact lenses regularly and have been diagnosed with Demodex blepharitis.

Not a fit: Patients who do not wear soft contact lenses or have not been diagnosed with Demodex blepharitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the comfort and quality of life for contact lens wearers suffering from Demodex blepharitis.

How similar studies have performed: Previous studies have shown promising results with similar treatments for eyelid conditions, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Be willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol
* Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at least Grade 1 erythema of the lower eyelid; and have a total meibomian gland secretion score ≥ 12 but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glands evaluated on the lower eyelid
* Currently wearing soft contact lenses on both eyes an average of at least 2 days per week with an average minimum wearing time of 6 hours each day over the past 3 months and is able and willing to continue to wear contact lenses during the study

Exclusion Criteria:

* Use of artificial tears or rewetting drops within 24 hours of the Screening visit or unwilling to forego the use of this treatment during the study
* Prescription AND systemic, drug delivery implant, ocular topical, or topical: antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14 days of the Screening or Day 1 visits
* Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14 days of the Screening visit or unwilling to forego the use of this treatment during the study
* Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc., within 12 months of the Screening visit
* Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorous acid-based products, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days of the Screening visit or unwilling to forego the use of these treatments during the study
* Use of artificial eyelashes or eyelash extensions at the Screening visit if they limit accurate eyelid margin assessment
* Currently pregnant or lactating

Where this trial is running

Cave Creek, Arizona and 13 other locations

• Site — Cave Creek, Arizona, United States (Recruiting)
• Site — Long Beach, California, United States (Recruiting)
• Vision Institute — Colorado Springs, Colorado, United States (Recruiting)
• Site — Delray Beach, Florida, United States (Recruiting)
• Site — Indianapolis, Indiana, United States (Recruiting)
• Site — Pittsburg, Kansas, United States (Recruiting)
• Site — Louisville, Kentucky, United States (Recruiting)
• Site — Edina, Minnesota, United States (Recruiting)
• Site — Shelby, North Carolina, United States (Recruiting)
• Site — Fargo, North Dakota, United States (Recruiting)
• Site — Powell, Ohio, United States (Recruiting)
• Site — Cranberry Township, Pennsylvania, United States (Recruiting)
• Site — Memphis, Tennessee, United States (Recruiting)
• Site — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Blake Simmons, OD — Vision Institute
• Study coordinator: Jen Anderson

Conditions Demodex Blepharitis; Soft contact lenses