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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Has initiated any new blepharitis or ocular surface treatment within the last 12 weeks
. The subject is only wearing a PROSE device in one eye.
. The participant is monocular
. The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications