2-week Dispensing Cross-Over Evaluation of Marketed Silicone Hydrogel Contact Lenses in an Indian Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Subjective Overall Comfort
研究概览
简要总结
The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.
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
- 是
入选标准
- •The subject must read, understand English, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be 18 and less than 40 years of age.
- •The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye.
- •The subject must have less than -1.00 D of cylindrical refraction.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
- •The subject must be an adapted soft contact lens wearer in both eyes.
- •The subject must have normal eyes.
排除标准
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- •Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- •Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer, or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- •Any ocular infections
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self report.
- •Employee of the investigational clinic (e.g. investigator, Coordinator, Technician)
研究组 & 干预措施
Test Lens 1
senofilcon A (Approved contact lens material)
干预措施: senofilcon A (Device)
Test Lens 1
senofilcon A (Approved contact lens material)
干预措施: lotrafilcon B (Device)
Test Lens 2
lotrafilcon B (Approved contact lens material)
干预措施: senofilcon A (Device)
Test Lens 2
lotrafilcon B (Approved contact lens material)
干预措施: lotrafilcon B (Device)
结局指标
主要结局
Subjective Overall Comfort
时间窗: 11 days Post fit
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Subjective Overall Quality of Vision
时间窗: 11 days post fit
Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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
未报告次要终点