Clinical Performance of Ocufilcon D With a Wetting Agent to Ocufilcon B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Lens Fit - Decentration After Insertion
研究概览
简要总结
This study is designed to evaluate ocufilcon D lens compared to ocufilcon B lens in a 1-week crossover, daily wear regimen.
详细描述
This study is designed to evaluate 2 daily disposable contact lenses that are both currently cleared for the USA market. Study of the ocufilcon D lens compared to the ocufilcon B lens in a 1-week crossover, daily wear regimen. The primary objective is the comparison of fitting characteristics. The secondary objective is the comparison of comfort, end of day comfort and dryness measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Has had a self reported oculo-visual examination in the last two years.
- •Is able to wear the study lenses for at least eight hours a day, seven days a week
- •Aged 18-40 years and has full legal capacity as a volunteer
- •Has a distance contact lens prescription from -0.25 and -6.00D inclusive
- •Has spectacle astigmatism of < 1.00D in each eye
- •Baseline vision of 20/20 best-corrected in each eye.
- •Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
- •Has read and understood the consent form and willing to sign consent form
- •Willing and able to follow participant instructions and attend the required study visits Has worn soft contact lenses for at least two weeks prior to the study (daily wear only).
排除标准
- •Currently wears contact lenses on an extended wear basis.
- •Not a current or past wearer of the ocufilcon B 52% 1-day lenses.
- •Has undergone anterior ocular surgery
- •Is aphakic
- •Has never worn contact lenses before
- •Has any systemic disease which clinically contraindicates contact lenses
- •Has active ocular disease or severe insufficiency of lacrimal secretion (dry eye)
- •Use of systemic or topical medications that will affect ocular health or visual performance
- •Slit lamp findings with a grading of greater than 1.0 using the grading scales in Appendix 3
- •Not possible to achieve a satisfactory fit with the lens design used in the study
- •Has keratoconus or other corneal irregularity
- •Participating in another eye-related clinical trial
- •Pregnant, lactating or planning a pregnancy
结局指标
主要结局
Lens Fit - Decentration After Insertion
时间窗: Baseline and 7 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).
Lens Fit - Tightness at One Week
时间窗: 7 days and 14 days from baseline visit
The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
Lens Fit - Post-Blink Lens Movement After Insertion
时间窗: Baseline and 7 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).
Lens Fit - Post-Blink Lens Movement Prior to Removal
时间窗: 7 days and 14 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).
Lens Fit - Decentration at One Week
时间窗: 7 days and 14 days from baseline visit
The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).
Lens Fit - Tightness After Insertion
时间窗: Baseline and 7 days from baseline visit
The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).
次要结局
- Overall Preference - Handling, Inserting(14 days from baseline visit)
- Overall Preference - Handling, Removing(14 days from baseline visit)
- Overall Lens Pair Preference(14 days from baseline visit)
- Overall Preference - Comfort After Insertion(14 days from baseline visit)
- Overall Preference - Comfort Before Removal(14 days from baseline visit)
- Overall Preference - Dryness After Insertion(14 days from baseline visit)
- Overall Preference - Dryness Before Removal(14 days from baseline visit)