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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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]:
- Completion of informed consent
- Review inclusion/exclusion criteria
- 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.
- 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:
- Best-Corrected Distance Visual Acuity (LogMAR)
- Slit Lamp Examination
- 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
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)
- Update: medical and ocular history, surgical history, social history, medications, allergies
- Review compliance with protocol
- 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
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 4
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Estelle Crowley, BS
- Numer telefonu: 7813078764
- E-mail: ecrowley@bostonsight.org
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:.
- 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
-
Exclusion Criteria:
- 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%
-
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Patients identified as having Demodex Blepharitis
This study has one arm which is the treatment arm
|
All subjects enrolled inthis study will be treated with xdemvy
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Ramy czasowe: Visit 1 - screening visit, Visit 2 - day 21, and Visit 3 - day 42
|
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
Ramy czasowe: Visit 1 - screening and Visit 3 - day 42
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Collarette grade
Ramy czasowe: Visit 1 - screening and Visit 3 - day 42
|
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.
|
Visit 1 - screening and Visit 3 - day 42
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Daniel Brocks, MD, Boston Sight
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BFS-Xdemvy-01
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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