Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 540
- 试验地点
- 35
- 主要终点
- Corneal Staining
研究概览
简要总结
The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.
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.
- •Be willing and able to adhere to the instructions set out in the protocol.
- •Be an existing successful daily wear soft contact lens wearer. 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 vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
- •Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
- •Achieve visual acuity of 6/9 (20/30) or better in each eye.
- •Require a visual correction in both eyes (no monovision allowed).
- •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 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
- •Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
- •Has had refractive surgery.
- •Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- •Abnormal lacrimal secretions.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Keratoconus or other corneal irregularity.
- •Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
- •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., Human immunodeficiency virus (HIV)].
- •History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
- •Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- •Participation in any concurrent clinical trial or in last 30 days
研究组 & 干预措施
galyfilcon A
Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
干预措施: galyfilcon A, BC 8.30 (Device)
lotrafilcon B
Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
干预措施: lotrafilcon B, BC 8.60 (Device)
comfilcon A
Subjects that were randomized to wear comfilcon A lens throughout the course of the study.
干预措施: comfilcon A, BC 8.60 (Device)
结局指标
主要结局
Corneal Staining
时间窗: after 2 weeks of contact lens wear
Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.
Overall Subjective Comfort
时间窗: after 2 weeks of contact lens wear
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
- Overall Subjective Lens Handling(after 2 weeks of contact lens wear)