Demodex Blepharitis in Scleral Lens Wearers

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