Comparing Habitual Daily Disposable Silicone Hydrogel (DDSH) Contact Lens Wearers to Habitual Daily Disposable Hydrogel (DDH) Contact Lens Wearers and Non-lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Bulbar Redness DDSH, DDH, Non-lens Groups
研究概览
简要总结
This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.
详细描述
The purpose of this study was to to compare physiological response baseline data between 3 groups - habitual wearers of Daily Disposable Silicone Hydrogel (DDSH) contact lenses, habitual wearers of Daily Disposable Hydrogel (DDH) contact lenses, and non-lens wearers. The study then compared physiological response data following wear of a low Dk HEMA contact lens between habitual wearers of DDSH and habitual wearers of DDH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is between 17 and 60 years of age inclusive (age matching required between all 3 study groups), and has full legal capacity to volunteer;
- •Has had a self-reported oculo-visual examination in the last two years.
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •No previous history of overnight contact lens wear or PMMA (polymethylmethacrylate) lens wear.
- •Auto-refraction vertexed spherical equivalent between +4.00 and -8.00 (prescription matching required between groups 1 & 2). This criterion is non-applicable to participants in group
- •Is found to be in one of the study groups matched by age (±5 years), ethnicity (Asian vs. non-Asian) and CL Rx (±2.00 D) according using the following criteria.
- •GROUP 1: For the past (minimum) 6 months has ONLY worn spherical DDSH lenses AND prior to wearing this lens they only wore SH material lenses in the past (minimum) 3 total years.
- •GROUP 2: For the past (minimum) 6 months has ONLY worn spherical DDH lenses AND prior to wearing this lens they only wore H material lenses in the past (minimum) 3 total years.
- •For groups 1 & 2, currently and for at least the previous 6 months has had habitual daily disposable wear schedule of at least 8 hrs a day, 5 days a week in only one material category - either silicone hydrogel or hydrogel material. This criterion is not-applicable to participants in group
- •Is willing to wear the study contact lens in the randomized eye for 3 hours of eye closure on the second study day. This criterion is not-applicable to participants in group
- •Has clear and healthy corneas and anterior eye and no active ocular disease;
- •Can achieve monocular HCVA of logMAR 0.10 or better in each eye with subjective refraction or pinhole.
- •Can achieve acceptable fit and comfort in the randomized eye with the study lens. This criterion will be confirmed at the baseline visit (V1). This criterion is not-applicable to participants in group
- •Has a wearable pair of spectacles.
排除标准
- •Is participating in any concurrent clinical trial;
- •Is unable/unwilling to provide permission for the study site to seek CL history from their eye care practitioner
- •Has any known active ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study measure or interfere with contact lens wear; this may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes, and systemic connective tissue disorders e.g. rheumatoid arthritis.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
- •Has known sensitivity to fluorescein dye, topical anesthetic, or products to be used in the study;
- •Appears to have any active ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
- •Appears to have any signs of corneal inflammation or previous infection or corneal opacity/scar;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit), due to potential ocular physiological changes, such as changes in the corneal shape and cell types;
- •Is aphakic;
- •Has undergone refractive error surgery, or has a history of any ocular surgery or injury.
- •Is a toric or multifocal contact lens wearer.
结局指标
主要结局
Bulbar Redness DDSH, DDH, Non-lens Groups
时间窗: 6-8 hours of habitual wear
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Limbal Redness - DDSH, DDH, Non-lens Groups
时间窗: 6-8 hours of habitual wear
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness after 6-8 hours of habitual device wear. For each participant, measurements were taken for both eyes (OD - right eye, OS - left eye) at two locations (T - temporal, N - nasal).
Bulbar Redness - DDSH, DDH Groups
时间窗: Immediately upon eye opening (baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of bulbar redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
Limbal Vessel Ingrowth - DDSH, DDH, Non-lens Groups
时间窗: 6-8 hours of habitual wear
Number of participants with limbal vessel ingrowth longer than 0.50 mm at any of the 4 corneal quadrants (superior, inferior, nasal, temporal) after 6-8 hours of device wear.
Limbal Redness - DDSH, DDH Groups
时间窗: Immediately upon eye opening (t=baseline) and lens removal (t=0), 1 hour (t=1), and 3 hours (t=3) post lens removal
Objective grading (0-4, severity increases in 0.1 steps; 0=no redness, 4=severe redness) of limbal redness by location (T - temporal, N - nasal) and time (t). Measurements were taken at baseline and over a 3 hour period of closed-eye Test Lens wear.
次要结局
- Central Corneal Swelling (%) - DDSH, DDH Groups(Immediately upon eye opening and lens removal (t=0), 0.5 hours (t=0.5), 1 hour (t=1), 2 hours (t=2), and 3 hours (t=3) post lens removal)