A Phase 4 interventional study of Xdemvy in Demodex Blepharitis, sponsored by Boston Sight. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Boston Sight · Phase 4, Interventional, and Treatment
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 functionality.
A total of up to SIX subjects with bilateral Demodex Blepharitis (> Grade 2, which is more than 10 collarettes of upper lash, in the worse eye) in a single clinic setting who currently wear scleral lenses on a daily basis for irregular corneas and/or ocular surface disease will be offered enrollment and will be included in the study The total duration of a subjects' participation in the study will be approximately 6 weeks.
Visit 1: Screening Visit [in person]:
a. Baseline questions b. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) c. Visual Analog Scale (VAS) questions assessing: i. Tolerability for desired daily PROSE wear time ii. Fluctuating vision iii. Ocular Burning iv. Ocular Redness v. Ocular Itching e. Clinical Examinations:
f. Imaging:
a. Standardized photographs of the upper and lower eyelids will be obtained. g. Diary
a. Daily subject diaries will be dispensed to subjects. Subjects will collect - i. PROSE device wear times (hours of wear each day) ii. Document each PROSE device application and removal
Document reason for removal iii. Document each dose instillation of Xdemvy iv. Document daily artificial tear use h. Dispense Xdemvy (lotilaner ophthalmic solution) 0.25% with instructions for use: one drop both eyes twice a day for 6 weeks. PROSE lenses should be removed prior to instillation of Xdemvy and may be reinserted 15 minutes following administration.8
Visit 2: Day 21 [3 day pre/post visit window] - Phone call
a. Update: medical and ocular history, surgical history, social history, medications, allergies b. Review compliance with protocol c. Symptom Questionnaire:
a. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) d. Diary
a. Reminder to complete daily diary
Visit 3: Day 42 [7 day pre/post visit window] (In-person)
a. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) b. Visual Analog Scale (VAS) questions assessing: i. Tolerability for desired daily PROSE wear time ii. Fluctuating vision iii. Ocular Burning iv. Ocular Redness v. Ocular Itching d. Clinical Examinations:
a. Best-Corrected Distance Visual Acuity (LogMAR) b. Slit Lamp Examination c. Collarette Scale (used in Saturn-1 and Saturn-2 clinical trials) e. Imaging:
a. Standardized photographs of the upper and lower eyelids will be obtained. f. Diary
a. Collection g. Medication
a. Collection
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Boston Sight is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:.
tolerability, blurred vision, ocular burning, ocular redness or ocular itching 9. In the opinion of the investigator, the subject can follow study instructions 10. In the opinion of the investigator, the subject can complete all study procedures and visits
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Exclusion Criteria:
Allergy to XDEMVY (lotilaner ophthalmic solution) 0.25%
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study has one arm which is the treatment arm
Drug: Xdemvy
All subjects enrolled inthis study will be treated with xdemvy
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is a validated 8-item, self-report tool developed by Chalmers et al. in 2012 to assess the frequency and intensity of soft contact lens (SCL) discomfort and dryness. A total score of \\(\\ge 12\\) indicates clinically significant discomfort and potential, which are strong predictors of patient dropout.
Time frame: Visit 1 - screening visit, Visit 2 - day 21, and Visit 3 - day 42
2. Visual analog scale (VAS) - Symptom and Lens Performance Scores
A Visual Analog Scale (VAS) is a subjective measurement tool, where individuals mark their symptom intensity (like pain, burning, or itching) to capture a continuous feeling not easily measured numerically. It's simple, widely used in healthcare for assessing symptom severity and treatment effectiveness, and recorded by measuring the distance from the "no" end, typically 0-100 mm. Subjects will complete VAS scales for Tolerability for desired daily PROSE wear time, Fluctuating vision, Ocular Burning, Ocular Redness, and Ocular Itching.
Time frame: Visit 1 - screening and Visit 3 - day 42
Collarette grade
A collarette grade is a clinical, non-linear scoring system (typically 0-4) used to quantify the severity of Demodex blepharitis by counting cylindrical dandruff-like debris (collarettes) at the base of eyelashes. It measures the infestation level, with higher grades indicating a higher percentage of lashes affected.
Time frame: Visit 1 - screening and Visit 3 - day 42
Ran from Apr 2026 to primary completion in Oct 2026, 5 months.
Primary completion moved twice since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, last on Oct 22, 2026.
Completion moved once since we started tracking on Sep 25, 2026: Feb 2027 → Oct 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lotilaner
Boston Sight