A Clinical Study of the Biofinity Energys Soft Contact Lens in Users of Digital Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Symptom of Itching
研究概览
简要总结
The aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.
详细描述
The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. Subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are between 18 and 35 years of age (inclusive).
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting, lasting up to one week).
- •They have a contact lens spherical prescription between -1.00 to -6.25D (inclusive) based on the ocular refraction.
- •They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
- •They own and habitually wear single vision spectacles used for both distance and near vision, including computer and digital device use.
- •Their single vision spectacles have a mean sphere equivalent within ±0.50D of that of the refraction found in the study for each eye (after having taken lens effectivity into account).
- •They are willing to be fitted with contact lenses and understand they may be randomized to either group.
- •They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
- •They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
- •They agree not to change the spectacles they will wear for digital device use for the duration of the study.
- •They agree not to participate in other clinical research for the duration of the study.
排除标准
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis.
- •The spectacles they use for digital device viewing on the study have been made with specialist features for computer use, digital eye fatigue or are multifocal/bifocal.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or breastfeeding.
- •They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- •They have evidence of a heterotropia or decompensating heterotropia on cover test.
- •They have a history of having been prescribed prism in their spectacles (by self report).
- •They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
结局指标
主要结局
Symptom of Itching
时间窗: Two Months
Symptom of itching measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Eye Pain
时间窗: Two Months
Symptom of eye pain measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Heavy Eyelids
时间窗: Two Months
Symptom of heavy eyelids measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Blurred Vision
时间窗: Two Months
Symptom of blurred vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Double Vision
时间窗: Two Months
Symptom of double vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Tearing
时间窗: Two Months
Symptom of tearing measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Feeling That Sight is Worsening
时间窗: Two Months
Symptom of feeling that sight is worsening measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Burning
时间窗: 2 months
Symptom of burning measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Feeling of Foreign Body
时间窗: Two Months
Symptom of feeling of foreign body measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Increased Sensitivity to Light
时间窗: Two Months
Symptom of increased sensitivity to light measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Colored Halos Around Objects
时间窗: Two Months
Symptom of colored halos around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Excessive Blinking
时间窗: Two Months
Symptom of excessive blinking measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Eye Redness
时间窗: Two Months
Symptom of eye redness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Dryness
时间窗: Two Months
Symptom of dryness measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Difficulty Focusing For Near Vision
时间窗: Two Months
Symptom of difficulty focusing for near vision measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Colored Haloes Around Objects
时间窗: One Month
Symptom of colored haloes around objects measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
Symptom of Headache
时间窗: Two Months
Symptom of headache measured by frequency on a scale of 0-2 (0-never, 1- occasionally, 2- often/always) and intensity on a scale of 1-2 (1- moderate 2- intense).
次要结局
未报告次要终点