NCT06098339已完成不适用
Performance Evaluation of Reusable Contact Lenses When Worn For One Month By Habitual Soft Contact Lens Wearers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Lens Handling on Removal
研究概览
简要总结
The purpose of this study was to compare the clinical performance of two different reusable lenses in habitual spherical soft lens wearers.
详细描述
This study was a prospective, bilateral eye, double-masked, randomized, 1 month cross-over, daily-wear design involving two different frequent replacement type lenses. Duration of involvement for each participant was approximately 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Were at least 18 years of age and no older than 39 years, and had full legal capacity to volunteer;
- •Had read and signed an information consent letter;
- •Were willing and able to follow instructions and maintain the appointment schedule;
- •Self-reported having had a full eye examination in the previous two years;
- •Had healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
- •Anticipated being able to wear the study lenses for at least 8 hours a day, 6 days a week;
- •Habitually wore spherical soft contact lenses, for the past 3 months minimum:
- •It was preferred that all participants were habitual frequent replacement lens wearers. However, if this was not possible then no more than 5 participants could be habitual daily disposable lens wearers at each site, the rest had to be habitual frequent replacement lens wearers;
- •For the frequent replacement wearers: No more than 3 could be habitual wearers of the Avaira Vitality™/ Serenity™ brand (or their equivalent private label brand name) and no more than 3 could be habitual wearers of AIR OPTIX® plus HydraGlyde® can be enrolled at each site;
- •Had refractive astigmatism no higher than -0.75DC in each eye;
- •Could be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).
排除标准
- •Were participating in any concurrent clinical or research study;
- •Had any known active ocular disease and/or infection that contraindicated contact lens wear;
- •Had a systemic or ocular condition that in the opinion of the investigator may have affected a study outcome variable;
- •Were using any systemic or topical medications that in the opinion of the investigator may have affect contact lens wear or a study outcome variable;
- •Had known sensitivity to the diagnostic sodium fluorescein used in the study;
- •Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Had undergone refractive error surgery or intraocular surgery.
结局指标
主要结局
Lens Handling on Removal
时间窗: Day 27
Participants measured subjective lens handling at removal on a 0-100 integer scale, where 0=worst and 100=best. Results for each lens were collected in the at-home diary on Day 27.
次要结局
未报告次要终点
研究者
研究点 (6)
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