Recruiting

Xdemvy with PROSE

Sponsor:

Boston Sight

Code:

NCT07561450

Conditions

Demodex Blepharitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xdemvy

Study Details

Brief summary:

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.

Conditions

Demodex Blepharitis

Study ID

NCT07561450

Start date

Apr 27, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 for frequency OR severity in ONE of the following:

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:

1. Is currently participating in any other type of eye-related clinical research study
2. Is pregnant or nursing as reported by the subject.
3. 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.
4. Has had previous ocular surgery within the past 12 weeks or has planned ocular surgery during the study period.
5. Has initiated any new blepharitis or ocular surface treatment within the last 12 weeks
6. The subject is only wearing a PROSE device in one eye.
7. The participant is monocular
8. The participant carries a diagnosis of glaucoma or ocular hypertension or glaucoma suspect AND is currently using glaucoma medications
9. Allergy to sodium fluorescein
10. Allergy to XDEMVY (lotilaner ophthalmic solution) 0.25%

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Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients identified as having Demodex Blepharitis

This study has one arm which is the treatment arm

Interventions

Xdemvy

All subjects enrolled inthis study will be treated with xdemvy

Primary outcome measure

  • 1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) [ 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 [ Time Frame: Visit 1 - screening and Visit 3 - day 42 ]

Central Contacts and Locations

Central contacts

Estelle Crowley, BS

7813078764ecrowley@bostonsight.org

Locations

BostonSight

Recruiting

Needham, Massachusetts, United States, 02494

Contacts

Estelle Crowley

7817267506ecrowley@bostonsight.org

More Information

Sponsor

Boston Sight

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • Blepharitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Boston Sight on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.