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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written Informed Consent has been obtained prior to any study-related procedures taking place
✓. Subject is Male or Female, 18 years of age or older prior to the initial visit
✓. Is an established wearer of PROSE devices for \> 6 months in both eyes
✓. Currently wears PROSE devices on a daily basis in both eyes
✓. No plans to alter the PROSE lens design in either eye during the study period
✓. Bilateral Demodex Blepharitis (\> Grade 2, which is more than 10 upper lash collarettes, worse eye)
✓. Baseline CLDEQ-8 score of 12 or higher
✓. Baseline VAS score of 40 or above for frequency OR severity in ONE of the following:
Exclusion criteria
✕. Is currently participating in any other type of eye-related clinical research study
✕. Is pregnant or nursing as reported by the subject.
✕. Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study.
✕. Has had previous ocular surgery within the past 12 weeks or has planned ocular surgery during the study period.
What they're measuring
1
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Timeframe: Visit 1 - screening visit, Visit 2 - day 21, and Visit 3 - day 42
2
2. Visual analog scale (VAS) - Symptom and Lens Performance Scores
Timeframe: Visit 1 - screening and Visit 3 - day 42