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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Estelle Crowley, BS
- 電話番号：7813078764
- メール：ecrowley@bostonsight.org
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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%
-
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Collarette grade
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Daniel Brocks, MD、Boston Sight
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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