Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- Comfort
研究概览
简要总结
The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.
详细描述
This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses;
- •Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);
- •Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;
- •Demonstrates an acceptable fit with the study lenses;
- •Is usually able to wear contact lenses for at least 8 hours per day.
排除标准
- •A person will be excluded from the study if he/she:
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;
- •Is aphakic;
- •Has undergone refractive error surgery.
- •Has participated in the previous somfofilcon A study (ORE# 20893)
- •For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
研究组 & 干预措施
Etafilcon A (control)
Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.
干预措施: somofilcon A (test) (Device)
Etafilcon A (control)
Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.
干预措施: etafilcon A (control) (Device)
Somofilcon A (test)
Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.
干预措施: etafilcon A (control) (Device)
Somofilcon A (test)
Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.
干预措施: somofilcon A (test) (Device)
结局指标
主要结局
Comfort
时间窗: 8 hours
Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.
Comfort Preference
时间窗: Baseline and 8 hours
Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens
Bulbar Hyperemia
时间窗: Baseline and 8 hours
Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Limbal Hyperemia
时间窗: Baseline and 8 hours
Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Conjunctival Staining
时间窗: 8 hours
Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Visual Acuity
时间窗: Baseline and 8 hours
High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.
次要结局
未报告次要终点