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

Launched by TARSUS PHARMACEUTICALS, INC. · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a new eye drop called XDEMVY in treating Demodex blepharitis, a condition caused by tiny mites on the eyelids that can lead to discomfort, especially for people who wear soft contact lenses. The study aims to see how well XDEMVY works compared to a placebo (an inactive version of the drop) and how it affects the experience of wearing contact lenses for those with this condition.

To participate, individuals need to be between the ages of 18 and 90, willing to follow the study guidelines, and currently wearing soft contact lenses regularly. They must also show signs of Demodex blepharitis in at least one eye. Participants will be asked to refrain from using certain eye treatments for a specific period during the study. Throughout the trial, they can expect to receive eye drops and have regular check-ups to monitor their progress. This study is currently recruiting participants, and it’s a great opportunity for those looking to find relief from this common eyelid issue.

Gender

ALL

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