Demodex Blepharitis in Scleral Lens Wearers
ConditionDemodex Blepharitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Sight
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Xdemvy
DrugAll subjects enrolled inthis study will be treated with xdemvy
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Patients identified as having Demodex BlepharitisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 422
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 42Secondary outcomes
1
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 42Sponsors and contacts
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Source ClinicalTrials.gov