Demodex Blepharitis in Scleral Lens Wearers

Demodex Blepharitis in Scleral Lens Wearers

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]:

1. Completion of informed consent
2. Review inclusion/exclusion criteria
3. Collect age, sex, race, ethnicity, social history (drug, alcohol and smoking), medical history, past ocular history, past ocular surgical history (including ocular and refractive surgery), allergies, medications, habitual contact lens use.
4. Symptom Questionnaires:

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:

1. Best-Corrected Distance Visual Acuity (LogMAR)
2. Slit Lamp Examination
3. Collarette Scale (used in Saturn-1 and Saturn-2 clinical trials)

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

1. 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)

   1. Update: medical and ocular history, surgical history, social history, medications, allergies
   2. Review compliance with protocol
   3. Symptom Questionnaires:

   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

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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