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
- 1
- 主要终点
- Comfort
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
研究组 & 干预措施
stenfilcon A
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
干预措施: filcon II 3 (Device)
filcon II 3
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
干预措施: stenfilcon A (Device)
结局指标
主要结局
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).
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).
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)
Daily and Comfortable Wearing Time
时间窗: Baseline
Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)
Vision Quality
时间窗: Baseline
Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Comfort
时间窗: Baseline
Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)
Dryness
时间窗: Baseline
Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)
Eye Whiteness
时间窗: Baseline
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: Baseline
Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Visual Acuity logMAR
时间窗: Baseline
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.
Visual Acuity logMAR
时间窗: Dispense
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.
次要结局
- Blood Vessel Coverage(1 Week)
- Corneal Staining(1 Week)
- Conjunctival Staining(1 Week)
- Conjunctival Redness(1 Week)
- Blood Vessel Coverage(Baseline)
- Conjunctival Redness(Baseline)
- Corneal Staining(Baseline)