Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Lens Fit - Post-blink Lens Movement
研究概览
简要总结
The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.
The primary outcome variables for this study are:
- Investigator responses to refit questions;
- Lens fit.
详细描述
This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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;
- •Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day;
- •Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses;
- •Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses;
- •Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction;
- •Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.
排除标准
- •Is participating in any concurrent clinical 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 pharmaceuticals to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication);
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Is an employee of the Centre for Contact Lens Research;
- •Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.
研究组 & 干预措施
somofilcon A 1-day soft contact lenses
Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week
干预措施: omafilcon A (Device)
somofilcon A 1-day soft contact lenses
Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week
干预措施: somofilcon A (Device)
结局指标
主要结局
Lens Fit - Post-blink Lens Movement
时间窗: Dispense and 1 Week
Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Lens Fit - Lens Tightness
时间窗: Dispense and 1 week
Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?
时间窗: 1 week
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Lens Fit - Lens Deposition
时间窗: Dispense and 1 week
Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film \>75% surface.
Lens Fit - Centration
时间窗: Dispense and 1 Week
(3 point scale: optimum, decentration acceptable, decentration unacceptable)
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?
时间窗: 1 week
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Overall Lens Fit Acceptance
时间窗: Dispense and 1 Week
Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less
Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?
时间窗: 1 week
Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?
时间窗: 1 week
Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)
Lens Fit - Lens Wettability
时间窗: Dispense and 1 Week
Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
次要结局
未报告次要终点