One-month Clinical Evaluation of Oté Sensation Multi-Purpose Solution Care System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 22
- 主要终点
- Comfort
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of the contact lens care product Oté Sensation in a representative population of soft contact lens wearers. For comparison, a widely used FDA approved soft lens multipurpose solution will be used as a control. This control product has been tested in previous clinical trials.
详细描述
This will be a 1-month, 200-subject, double-masked (care product), bilateral, randomized, comparative study. Subjects will be clinically evaluated at the initial baseline visit (Visit 1), then after 1 week and 1 month of lens wear having been randomly assigned to use one of six lens types and to either the test or control solutions.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a currently adapted soft contact lens wearer (>1 month of lens wear).
- •Be at least 18 years of age.
- •Refractive astigmatism <0.75 D in both eyes.
- •Have clear corneas and be free of any anterior segment disorders.
- •Be correctable through spherocylindrical refraction to 6/12 (20/40) (0.30 LogMAR) or better in each eye.
- •Contact lens sphere requirement between +4.00 Dioptre and -8.00 D (inclusive).
- •Require visual correction in both eyes (monovision allowed, no monofit).
- •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 strabismus
- •No evidence of lid abnormality or infection
- •No conjunctival abnormality or infection that would contraindicate contact lens wear
- •No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
- •No other active ocular disease.
排除标准
- •Require toric or multifocal contact lenses.
- •Previously shown a sensitivity to any of the study solution components.
- •Any systemic or ocular disease or allergies affecting ocular health.
- •Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
- •Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
- •Keratoconus or other corneal irregularity.
- •Aphakia or amblyopia.
- •Have undergone corneal refractive surgery or any anterior segment surgery.
- •Abnormal lacrimal secretions.
- •Has diabetes.
- •Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •History of chronic eye disease (e.g. glaucoma).
- •Pregnant or lactating or planning a pregnancy at the time of enrolment.
- •Participation in any concurrent clinical trial or in last 30 days.
结局指标
主要结局
Comfort
时间窗: Up to 4 weeks
Subjective comfort(during the day). Subject grading comfort of lenses 0-10 (Higher scores indicates the subjects greater comfort with the lenses.)
Bulbar Hyperemia
时间窗: Up to 4 weeks
Assessed using slit lamp with white light, low-medium magnification 0-4 ( 4= Severe)
Lens Surface Wetting
时间窗: Up to 4 weeks
Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0-4 scale (4 = Excellent)
Limbal Hyperemia
时间窗: Up to 4 weeks
Assessed using slit lamp with white light, low-medium magnification. 0-4 ( 4= Severe)
Visual Acuity (VA)
时间窗: Visual Acuity was assessed for all participants after 2 weeks from day of dispensing lens solution and then again at the final evaluation at the 1 month visit.
Monocular and binocular high contrast Visual Acuity (VA) was measured at each visit and evaluated using a LogMAR VA Chart where the size of the letters become increasingly smaller from the top of the chart to the bottom of the chart. On this scale, the minimum VA (Worst achievable) is +1.00 LogMAR and the maximum value (Best achievable) is -0.30 LogMAR. Each line of the chart (a total of five letters per line) is equivalent to -0.10 LogMAR and each letter read is equivalent to -0.02. The lower the score/measurement , indicate a better VA obtained. Participants were positioned at a distance of three meters from the eye chart and asked to start reading letters from the top line and to continuing reading letters until they are unable to correctly identify three letters on any given line. The Visual Acuity was recorded to the nearest letter.
Film Deposits
时间窗: Up to 4 weeks
Any film deposits (protein/lipid) attached to the front surface of the lens. Scan the entire lens surface (10- 20X) for the presence of deposits. 0-4 (4= Heavy film)
Corneal Staining
时间窗: Up to 4 weeks
Assessed using a slit lamp by sector with fluorescein, blue light, yellow filter and full beam using a medium magnification. Cornea staining will be assessed by sector (Central, Nasal, Temporal, Inferior, Superior) using a 0-4 scale where 0-4 is the total corneal staining score and higher staining score indicates a worse outcome.
次要结局
未报告次要终点