Demodex Blepharitis in Scleral Lens Wearers

NCT07561450 | Not Yet Recruiting Phase 4

• 1 other identifier: BFS-Xdemvy-01
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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

Keywords

Blepharitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Visit 1 - screening and Visit 3 - day 42

Secondary Outcomes (1)

• Collarette grade

  Visit 1 - screening and Visit 3 - day 42

Study Arms (1)

Patients identified as having Demodex Blepharitis

EXPERIMENTAL

This study has one arm which is the treatment arm

Drug: Xdemvy

Interventions

Xdemvy DRUG

All subjects enrolled inthis study will be treated with xdemvy

Patients identified as having Demodex Blepharitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• 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
• Allergy to sodium fluorescein
• Allergy to XDEMVY (lotilaner ophthalmic solution) 0.25%

Sponsors & Collaborators

• Boston Sight: lead

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Daniel Brocks, MD

  Boston Sight

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estelle Crowley, BS

CONTACT

7813078764; ecrowley@bostonsight.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 1, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04