Evaluation of the CooperVision Stenfilcon A Soft Contact Lens for Daily Wear When Compared to the CooperVision Ocufilcon B Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
研究概览
简要总结
This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.
详细描述
This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Prior to being considered eligible to participate in this study, each subject MUST:
- •Be at least 18 years of age as of the date of evaluation for the study.
- •Read the Informed Consent
- •been given an explanation of the Informed Consent
- •indicated understanding of the Informed Consent
- •signed the Informed Consent document.
- •Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- •Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
- •Possess wearable and visually functional eyeglasses.
- •Be in good general health, based on his/her knowledge.
- •Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
- •Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
- •Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.
排除标准
- •Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
- •Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- •Poor personal hygiene.
- •Any active participation in another clinical trial within 30 days prior to this study.
- •Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
- •A member, relative or household member of the investigator or of the investigational office staff.
- •Has a known sensitivity to ingredients used in the over the counter contact lens lubricants approved for use in the study.
- •Previous refractive surgery; or current or previous orthokeratology treatment.
- •Is aphakic or psuedophakic.
- •Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
- •The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day.
- •The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- •A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
- •A history of papillary conjunctivitis that has interfered with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- •Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2
- •Pterygium
- •Corneal scars within the visual axis
- •Neovascularization or ghost vessels > 1.0 mm in from the limbus
- •Giant papillary conjunctivitis (GPC) of > Grade 2
- •Anterior uveitis or iritis
- •Seborrheic eczema, seborrheic conjunctivitis or blepharitis
- •To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.
- •To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.
结局指标
主要结局
Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
时间窗: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined
The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
时间窗: Any occurrence from dispensing to month 3 visit
The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).
Objective Assessment: Ocular Response - Biomicroscopy
时间窗: Change from baseline visit and all follow-ups visits
The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.
次要结局
- Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort(Baseline, Week 1, Week 2, Month 1, Month 2, Month 3)
- Evaluation of Average Lens Wearing Time - Average Daily Hours Worn(Baseline, Week 1, Week 2, Month 1, Month 2, Month 3)