Demodex Blepharitis in Scleral Lens Wearers
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- 1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •In the opinion of the investigator, the subject can follow study instructions
- •In the opinion of the investigator, the subject can complete all study procedures and visits
排除标准
- •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%
研究组 & 干预措施
Patients identified as having Demodex Blepharitis
This study has one arm which is the treatment arm
干预措施: Xdemvy (Drug)
结局指标
主要结局
1. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
时间窗: 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.
2. Visual analog scale (VAS) - Symptom and Lens Performance Scores
时间窗: 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.
次要结局
- Collarette grade(Visit 1 - screening and Visit 3 - day 42)
研究者
Daniel C Brocks
Chief Medical Officer
Boston Sight