Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Monocular Visual Acuity on LogMAR Scale
研究概览
简要总结
The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be between 18 and 40 years old.
- •The subject must have normal eyes.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
- •The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
- •The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
- •The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
- •The subject must be an adapted wearer of soft toric contact lenses in both eyes.
- •The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
- •Subjects must already possess a wearable pair of spectacles.
排除标准
- •Ocular or systemic allergies or disease that may interfere with contact lens wear.
- •Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Pregnancy or lactation
- •Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •Strabismus
研究组 & 干预措施
Etafilcon A toric contact lens/Nelfilcon A toric
Etafilcon A toric contact lens first, then nelfilcon A toric second
干预措施: Etafilcon A toric contact lens (Device)
Etafilcon A toric contact lens/Nelfilcon A toric
Etafilcon A toric contact lens first, then nelfilcon A toric second
干预措施: Nelfilcon A toric contact lens (Device)
Nelfilcon A toric/ Etafilcon A toric
Nelfilcon A toric contact lens first, then etafilcon A toric toric second
干预措施: Etafilcon A toric contact lens (Device)
Nelfilcon A toric/ Etafilcon A toric
Nelfilcon A toric contact lens first, then etafilcon A toric toric second
干预措施: Nelfilcon A toric contact lens (Device)
结局指标
主要结局
Monocular Visual Acuity on LogMAR Scale
时间窗: After 5 to 9 days of lens wear
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Binocular Visual Acuity on LogMAR Scale
时间窗: After 5 to 9 days of lens wear
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
时间窗: After 5 to 9 days of lens wear
The Contact Lens User Evaluation(CLUE)TM questionnaire is 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
时间窗: After 5 to 9 days of lens wear
The Contact Lens User Evaluation(CLUE)TM questionnaire is 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
次要结局
未报告次要终点