Boston Sight
The purpose of this study will be to see if Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance. The investigators hypothesize the use of Xdemvy in subjects utilizing PROSE treatment will be well tolerated and that the reduction in Demodex mite load on the eyelid margin will result in reduced ocular surface symptoms and improved PROSE tolerance and functionality.
This proof-of-concept study will investigate whether standard, on label, six-week treatment of Demodex Blepharitis (DB) with Xdemvy (lotilaner ophthalmic solution) 0.25% has a positive impact on ocular surface symptoms and PROSE device functionality and performance. The investigators hypothesize the use of Xdemvy in subjects utilizing PROSE treatment will be well tolerated and that the reduction in Demodex mite load (measured utilizing the surrogate, validated endpoint of lash collarettes 6,7) on the eyelid margin will result in reduced ocular surface symptoms and improved PROSE tolerance and…
Inclusion Criteria:. 1. Written Informed Consent has been obtained prior to any study-related procedures taking place 2. Subject is Male or Female, 18 years of age or older prior to the initial visit 3. Is an established wearer of PROSE devices for \> 6 months in both eyes 4. Currently wears PROSE devices on a daily basis in both eyes 5. No plans to alter the PROSE lens design in either eye during the study period 6. Bilateral Demodex Blepharitis (\> Grade 2, which is more than 10 upper lash collarettes, worse eye) 7. Baseline CLDEQ-8 score of 12 or higher 8. Baseline VAS score of 40 or above…
All subjects enrolled inthis study will be treated with xdemvy
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