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

Completed · Phase 4

Conditions studied: Demodex Blepharitis

In brief

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.

Key facts

Study ID

NCT06182358

Run by

Tarsus Pharmaceuticals, Inc.

People needed

145

Starts

2023-12-27

Expected to finish

2025-01-27

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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