Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 452
- 试验地点
- 28
- 主要终点
- Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B
研究概览
简要总结
The objective of the study is to compare the clinical performance of silicone hydrogel daily disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone hydrogel monthly replacement contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Be no less than 18 and no more than 39 years of age.
- •Sign Written Informed Consent and investigator to record this on Case Report Form (See separate document).
- •Be willing and able to adhere to the instructions set out in the protocol.
- •Own a cell phone and be willing to receive text messages during the day.
- •Be an existing successful daily wear soft contact lens. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
- •No extended wear in the last 3 months.
- •Subjective refraction must result in a vertexed spherical contact lens prescription between -1.00 and -6.00D.
- •Have refractive astigmatism less than or equal to 1.00D in both eyes.
- •Achieve visual acuity of 6/9 (20/30) or better in each eye.
- •Require a visual correction in both eyes (no monofit or monovision allowed).
- •Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
- •Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia.
- •No evidence of lid abnormality or infection (including blepharitis/meibomitis).
- •No conjunctival abnormality or infection.
- •No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
- •No other active ocular disease.
排除标准
- •Requires concurrent ocular medication.
- •Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Clinically significant corneal staining (Grade 3 in more than one corneal region per eye).
- •Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
- •Has had refractive surgery.
- •Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- •Abnormal lacrimal secretions.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Keratoconus or other corneal irregularity.
- •PMMA(polymethyl methacrylate), hybrid or RGP(rigid gas permeable) lens wear in the previous 8 weeks.
- •Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •Diabetic.
- •Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV (Human immunodeficiency virus)).
- •History of chronic eye disease (e.g. glaucoma or ARMD (age related macular degeneration)).
- •Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- •Participation in any concurrent clinical trial or in last 30 days.
研究组 & 干预措施
narafilcon B daily disposable 4 weeks
narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
干预措施: narafilcon B contact lens (Device)
nelfilcon A daily disponsable 1 week
nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week
干预措施: nelfilcon A contact lens (Device)
lotrafilcon B daily wear, monthly replacement, 4-weeks
lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks
干预措施: lotrafilcon B contact lens (Device)
结局指标
主要结局
Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B
时间窗: After 4 Weeks
Redness scale of 0 to 4, where 0=None, and 4=Severe.
Overall Comfort Narafilcon B v. Nelfilcon A
时间窗: After 1 week
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A
时间窗: After 1 Week
Redness scale of 0 to 4, where 0=None, 4=Severe redness
Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B
时间窗: After 4 Weeks
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
次要结局
- Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A(After 1 Week)
- Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A(After 1 Week)
- Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A(After 1 Week)
- Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A(After 1 Week)
- Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B(After 4 Weeks)
- Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B(After 4 Weeks)
- Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B(After 4 Weeks)
- Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B(After 4 Weeks)