NCT00762385已完成不适用
Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 主要终点
- Lens Comfort
研究概览
简要总结
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
- •The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
- •The subject, based on his/her knowledge, must be in good general health.
- •The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
- •Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
- •Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
- •Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
- •The subject must read, indicate understanding of and sign the Informed Consent Form.
排除标准
- •The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
- •The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
- •The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
- •Slit lamp findings that would contraindicate contact lens wear such as:
- •pathological dry eye or associated findings
- •pterygium or corneal scars within the visual axis
- •neovascularization equal to or greater than 1mm in from the limbus
- •history of giant papillary conjunctivitis (GPC) worse than grade 2
- •anterior uveitis or iritis (past or present)
- •seborrhoeic eczema
- •seborrhoeic conjunctivitis
- •A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
- •A known history of corneal hypoesthesia (reduced corneal sensitivity).
- •Contact lens snellen visual acuities (VA) worse than 20/
- •Aphakia, keratoconus or a highly irregular cornea.
- •Current pregnancy or lactation (to the best of the subject's knowledge)
- •Any active participation in another clinical study at any time during this study.
研究组 & 干预措施
galyfilcon A/comfilcon A
Active Comparator
galyfilcon A first, comfilcon A second
干预措施: galyfilcon A (Device)
galyfilcon A/comfilcon A
Active Comparator
galyfilcon A first, comfilcon A second
干预措施: comfilcon A (Device)
comfilcon A/galyfilcon A
Active Comparator
comfilcon A first, galyfilcon A second
干预措施: galyfilcon A (Device)
comfilcon A/galyfilcon A
Active Comparator
comfilcon A first, galyfilcon A second
干预措施: comfilcon A (Device)
结局指标
主要结局
Lens Comfort
时间窗: 1-week, 2- weeks
\>0 = comfortable, \<0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.
Comfort Symptoms
时间窗: 1-week, 2-weeks
A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. \>0 = comfortable, \<0 = uncomfortable
次要结局
- Overall Corneal Staining(2 weeks)
研究者
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