A Single Arm, Single Center Phase 4 Study to Evaluate Impact of a Single Systane iLux MGD Treatment Device Thermal Pulsation Treatment on Contact Lens Wearing Time and Tolerability, Meibomian Gland Secretion Scores, and Subjective Dry Eye Symptoms in Soft Contact Lens Wearing Subjects With Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month
研究概览
简要总结
To evaluate dry eye symptoms and contact lens wearing times after a single iLux treatment by evaluating change from baseline in OSDI scores, subjective CLDEQ8 and CL wearing time questionnaires, and meibomian gland secretion scores.
详细描述
A single arm, single center phase 4 study to evaluate impact of a single Systane iLux MGD Treatment Device thermal pulsation treatment on contact lens wearing time and tolerability, meibomian gland secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.
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
- 是
入选标准
- •Eligible subjects must be 18 years of age or older
- •Eligible subjects must be willing and able to provide an English language written Informed Consent Form
- •Be a current soft contact lens wearer for at least 2-18 hours a day 4-7 days a week but experiencing contact lens discomfort that limits the number of hours of comfortable contact lens wear.
- •Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days
- •Have new contact lens to wear starting the first day after iLux treatment
- •Have an OSDI score greater than ≥ 12
- •Have a CLDEQ8 score ≥ 12
- •Have a minimum meibomian gland expression score ≤ 12 (using MGD scoring system: apply pressure with korb expressor to 15 glands of lower lid (5 nasal, 5 central, 5 temporal): each gland will be scored from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid), sum of score from each gland with equal total score, total score will range from 0-
- •Be able and willing to follow instructions and participate in all trial assessments and visits
- •Eligible subjects must be fully vaccinated against COVID-19
排除标准
- •Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters
- •Have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering iLux treatment
- •Had Lipiflow, iLux, Tear Care or manual meibomian gland expression in the last 30 days
- •Be a woman who is pregnant, nursing, or planning a pregnancy
- •Had ocular surgery within the last 90 days
- •Have used topical cyclosporine, lifitegrast, topical or facial steroids, serum tears, or oral doxycycline or tetracycline within the last 30 days before Visit 1
- •Had Intense Pulsed Light (IPL) treatment within last 30 days
- •Have active ocular infection or inflammation
- •Be a current wearer of extended wear contact lenses
结局指标
主要结局
Percentage of subjects with improvement in CLDEQ8 Questionnaire score from baseline to 1 month
时间窗: 1 month
CLDEQ8 (Contact Lens Dry Eye Questionnaire) is a subjective contact lens discomfort and dryness questionnaire. A lower CLDEQ8 score represents less frequent and/or less severe symptoms
Percentage of subjects with improvement in MGSS from baseline to 1 month
时间窗: 1 month
MGSS (Meibomian gland secretion score). To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.
Percentage of subjects with improvement in comfortable SCL (soft contact lens) wearing time from baseline to 1 month
时间窗: 1 month
Total comfortable soft contact lens wearing time per week will be asked via questionnaire.
Percentage of subjects with improvment in OSDI Questionnaire score from baseline to 1 month
时间窗: 1 month
OSDI (Ocular Surface Disease Index) is a subjective dry eye symptom questionnaire. A lower OSDI score represents less frequent and/or less severe symptoms.
Percentage of subjects with dryness symptoms who reported wearing their contact lenses longer, 1 month post treatment.
时间窗: 1 month
Total soft contact lens wearing time per week will be asked via questionnaire.
次要结局
- Mean change in TBUT from baseline to 1 month(1 month)
- Mean change in Sodium Fluorescein and Lussamine Green staining from baseline to 1 month(1 month)