Evaluation of Stenfilcon A Versus Etafilcon A
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
- Participant's Subjective Rating of Dryness (Questionnaire)
研究概览
简要总结
Evaluation of two contact lenses
详细描述
One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •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 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
- •Has astigmatism less than or equal to -1.00D;
- •Is an adapted soft contact lens wearer;
- •Demonstrates an acceptable fit with the study lenses;
- •Has no active anterior segment disease or known ocular disease.
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before;
- •Has any systemic disease affecting ocular health;
- •Is using any systemic or topical medications that will affect ocular health;
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
- •Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- •Is aphakic;
- •Has undergone corneal refractive surgery;
- •Is participating in any other type of clinical or research study;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
研究组 & 干预措施
Etafilcon A
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
干预措施: Stenfilcon A (Device)
Stenfilcon A
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
干预措施: Etafilcon A (Device)
结局指标
主要结局
Participant's Subjective Rating of Dryness (Questionnaire)
时间窗: 12-hours, 1-week
Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
时间窗: Dispense
Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing
Participant's Subjective Rating of Overall Preference (Questionnaire)
时间窗: 12-hours, 1-week
Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Comfort (Questionnaire)
时间窗: Insertion, After Lens settling, 12-hours, 1-week
Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week
Participant's Subjective Rating of Visual Quality (Questionnaire)
时间窗: 12-hours, 1-week
Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
时间窗: 12-hours, 1-week
Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week
次要结局
- Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)(Insertion, 12 hours, 1 week)
- Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)(Insertion, 12 hours, 1 week)
- Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)(Baseline, 12-hours, 1-week)
- Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)(Insertion, 12-hours, 1-week)
- Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)(Insertion)
- Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)(Baseline, 12-hours, 1-week)