Evaluation of Fit and Visual Acuity of the Investigational Toric Lens in Two Phases: Part B: A Dispensing Cross-over Comparison to SofLens66 Toric
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Subject Reported Lens Comfort.
研究概览
简要总结
The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.
详细描述
Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.
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
- •Prior to being considered eligible to participate in this study, subjects 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 (monovision or uniocular fitting is NOT allowed).
- •be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy.
- •have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
- •be able and willing to adhere to the instructions set forth in the protocol.
- •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.
- •have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
- •have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
- •be in good general health, based on his/her knowledge.
- •read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.
排除标准
- •The subject is a rigid gas permeable (RGP) or daily disposable soft 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., Sjögren'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 >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.)
- •Aphakia, keratoconus or a highly irregular cornea.
- •Current pregnancy or lactation (to the best of the subject's knowledge).
- •Active participation in another clinical study at any time during this study.
结局指标
主要结局
Subject Reported Lens Comfort.
时间窗: 1 week
A weighted combined score of one week and two week data calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the estimates for senofilcon A and alphafilcon A, respectively. Interpretation is \>0 indicates comfortable and \<0 indicates uncomfortable.
Subjective Reported Vision
时间窗: 1 week
A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score \>0 then greater vision, if \<0 then lesser vision.
次要结局
未报告次要终点