Single-Center Clinical Evaluation of Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall Lens Preference - Hydrogel vs. Filcon II 3
研究概览
简要总结
The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.
详细描述
Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is between 18 and 40 years of age (inclusive)
- •Has had a self-reported visual exam in the last two years
- •Is an adapted soft CL wearer
- •Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
- •Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- •Has less than 1.25 D spectacle cylinder in each eye.
- •Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- •Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
- •Has clear corneas and no active ocular disease
- •Has read, understood and signed the information consent letter
- •Is willing to comply with the wear schedule (at least 3 full days)
- •Is willing to comply with the visit schedule
排除标准
- •Has never worn contact lenses before.
- •Currently wears rigid gas permeable contact lenses.
- •Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)
- •Has a CL prescription outside the range of - 1.00 to -6.00D
- •Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
- •Has best corrected spectacle distance vision worse then 20/25 in either eye.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion
- •Has persistent, clinically significant corneal or conjunctival staining
- •Has active neovascularization or any central corneal scars.
- •Is aphakic.
- •Is presbyopic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
研究组 & 干预措施
etafilcon A lens
Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
干预措施: etafilcon A (Device)
nelfilcon A lens
Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
干预措施: nelfilcon A (Device)
filcon II 3 lens
Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
干预措施: filcon II 3 (Device)
结局指标
主要结局
Overall Lens Preference - Hydrogel vs. Filcon II 3
时间窗: Study Exit
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Overall Lens Preference - All Study Lenses
时间窗: Study Exit
Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
次要结局
- Subjective Response for Insertion(Baseline)
- Subjective Response for Vision(Baseline and 3 day follow-up)
- Overall Satisfaction, Handling(3 Days)
- Overall Satisfaction(3 Days Follow-up)
- Overall Satisfaction, Comfort(3 Days Follow-up)
- Subjective Response for Comfort(Baseline and 3 day follow-up)
- Overall Satisfaction, Vision(3 Days Follow-up)
- Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)(Baseline and 3 days follow-up)
- Subjective Response for Handling (Insertion and Removal)(3 days follow-up)
- Subjective Response for Dryness(3 Days Follow-up)
- Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)(Baseline and 3 day follow-up)
- Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)(Baseline and 3 day follow-up)
- Overall Satisfaction, Dryness(3 Days Follow-up)
- Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)(Baseline and 3 days follow-up)
- Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)(Baseline and 3 days follow-up)
- Ocular Health - Biomicroscopy(3 Days Follow-up)
- Lens Fit and Performance - Fit Acceptance(Baseline and 3 day follow-up)