NCT03168542已完成不适用
Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of Fitting Modifications to Optimize Vision
研究概览
简要总结
This study is a single arm, non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
- •The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
- •The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
- •The subject's distance spherical equivalent or spherical component (if the eye has - 1.00 to -1.50 D of refractive cylinder) of their refraction must be in the range -1.25 D to -3.75 D or +1.25 D to +3.75 D in each eye.
- •The subject's refractive cylinder cannot be greater than -1.50D in either eye.
- •The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
- •The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
- •The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- •The subject must have a wearable pair of spectacles if required for their distance vision.
排除标准
- •Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
- •Pregnancy or lactation.
- •Currently diagnosed with diabetes.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
- •Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
- •Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
- •A history of amblyopia, strabismus or binocular vision abnormality.
- •Any ocular infection or inflammation.
- •Any ocular abnormality that may interfere with contact lens wear.
- •Use of any ocular medication, with the exception of rewetting drops.
- •History of herpetic keratitis.
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- •Employee of clinical site (e.g., Investigator, Coordinator, Technician)
结局指标
主要结局
Number of Fitting Modifications to Optimize Vision
时间窗: 15 Minutes Post Lens Fitting
The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.
次要结局
- Subject's Responses to Individual Item 2(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 4(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 9(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 7(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 1(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 3(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 5(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 6(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 8(15 Minutes Post Lens Insertion)
- Subject's Responses to Individual Item 10(15 Minutes Post Lens Insertion)
研究者
研究点 (2)
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