Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- overall ocular comfort
研究概览
简要总结
This study is being conducted to determine if scleral lenses treated with Hydra-PEG improve comfort and dryness.
详细描述
The objective of the study is to determine if scleral lenses with and scleral lenses without Hydra-PEG treatment provide positive improvement in ocular comfort and dryness scores.
The effect of the study lenses and the treatment, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers.
The primary outcome variable for this study is "overall ocular comfort" reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
At the fitting visit, only uncoated lenses will be used to determine the parameters of the lenses to be ordered. At both dispense visits, participants and investigators will be masked to the lens type dispensed. In order to achieve this, unmasked study personnel will determine the order of lens wear according to the randomization schedule and they will not share the lens labels or packs with the investigator. Instead, the lenses will be transferred to an unmarked case/container prior to being provided at the Dispense visit.
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are at least 17 years of age and have full legal capacity to volunteer;
- •Have read and signed an information consent letter;
- •Are willing and able to follow instructions and maintain the appointment schedule;
- •Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week;
- •Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye;
- •Have best corrected visual acuity of 20/40 or better in each eye with the study lenses;
- •Demonstrate an acceptable fit with the study lenses;
- •Have no active ocular disease or inflammation;
- •Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses;
- •Group 2: Have not worn contact lenses for 6 months;
- •Group 1: Contact lens wearers should score ≥12 on CLDEQ-8;
- •Group 2: Non contact lens wearers should score ≥13 on OSDI.
排除标准
- •Are participating in any concurrent clinical or research study, or have done so within the past 30 days;
- •Cannot achieve a successful lens fit or vision with the study lens;
- •Have been diagnosed with keratoconus or corneal distortion;
- •Have any known active* ocular condition, disease and/or infection;
- •Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae;
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Group 2: Non-contact lens wearers who score ≥33 on OSDI and also demonstrate either corneal staining ≥3 (Oxford scale) or non-invasive tear break-up time ≤3 seconds#;
- •Have known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- •Are pregnant, lactating or planning a pregnancy^ at the time of enrolment, by self report;
- •Have undergone refractive error surgery;
- •Are listed on the Delegation Log for this study.
研究组 & 干预措施
Habitual Soft Lens Wearers
Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.
干预措施: scleral lens (Device)
Non Contact Lens Wearers
Each group will be a prospective, randomized, double masked, cross-over, 1-month per arm, daily wear study. Each participant will be active in the study for at least 2 months.
干预措施: scleral lens (Device)
结局指标
主要结局
overall ocular comfort
时间窗: 4 weeks
reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps)
次要结局
未报告次要终点