Clinical Performance of Stenfilcon A Versus Filcon II 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Daily and Comfortable Wearing Time
研究概览
简要总结
Clinical Performance of Stenfilcon vs. Filcon II 3
详细描述
The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (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
- 否
入选标准
- •Subjects must satisfy the following conditions prior to inclusion in the study:
- •Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
- •Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
- •Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
- •Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
- •Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.
- •An existing soft contact lens wearer of any modality.
- •Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
- •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 evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
- •No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).
- •No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
- •No aphakia
排除标准
- •Any of the following will render a subject ineligible for inclusion:
- •Neophytes, who have not worn lenses before
- •Greater than 0.75D of refractive astigmatism in either eye
- •Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- •Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear such as:
- •Pathological dry eye or associated findings
- •Pterygium, pinguecula or corneal scars within the visual axis
- •Neovascularization > 0.75 mm in from the limbus
- •Giant papillary conjunctivitis (GPC) Grade 3 or above
- •Anterior uveitis or iritis (past or present)
- •Seborrheic eczema, seborrheic conjunctivitis
- •History of corneal ulcer or fungal infections
- •Poor personal hygiene
- •A known history of corneal hypoesthesia (reduced corneal sensitivity).
- •Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
- •Aphakia, Keratoconus or a highly irregular cornea
结局指标
主要结局
Daily and Comfortable Wearing Time
时间窗: 1 week
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)
Dryness
时间窗: 1 Week
Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Comfort
时间窗: 1 Week
Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Eye Whiteness
时间窗: 1 Week
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Overall Satisfaction
时间窗: 1 Week
Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Visual Acuity logMAR
时间窗: 1 Week
Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR
Wettability
时间窗: 1 Week
Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.
Handling
时间窗: 1 Week
Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).
Vision Quality
时间窗: 1 Week
Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
次要结局
- Blood Vessel Coverage(1 Week)
- Corneal Staining(1 Week)
- Conjunctival Staining(1 Week)
- Conjunctival Redness(1 Week)