Clinical Evaluation of the Clinical Performance and Safety of a New Monthly Disposable Silicone Hydrogel Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Permanent loss of visual acuity
研究概览
简要总结
To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens
详细描述
This study is a prospective, subject-masked, bilateral, randomized, parallel group dispensing study comparing the SHSCL test lens against the 1-Month ACUVUE® VITA™ (1-MAV) control lenses. Each subject will be randomized to wear either the test or of the control with similar/comparable lens parameters optimized for vision.
Both test and control lens will be used in their daily wear, monthly replacement modality for thirteen (13) weeks. It is anticipated that this study will involve up to 6 scheduled visits.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Healthy adult males or females age ≥20-45 years of age;
- •Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment) and the last contact lenses worn more than a week ago;
- •Have a contact lens powers between -2.00D and -6.00D (both inclusive) in both eyes;
- •Astigmatism of 1.00D or less in both eyes;
- •Be able to wear the lens powers available for this study;
- •Be correctable to a visual acuity of 0.8 decimal (+0.10 logMAR) or better in each eye;
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
- •The subject must read and sign the Informed Consent form.
排除标准
- •A person will be excluded from the study if he/she:
- •Previously unsuccessful with contact lens wear, worn rigid gas permeable contact lenses within past 12 months;
- •Women who are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- •Any ocular or systemic allergies or diseases that may contraindicate contact lens wear;
- •Any ocular medications use within the last one month;
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear;
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report;
- •Any current or previous orthokeratology treatment, or planned for orthokeratology treatment during the study;
- •Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or planned for ocular and/or refractive surgery during the study
- •History of herpetic keratitis;
- •History of binocular vision abnormality or strabismus, by self-report;
- •Allergic reactions to test lens, control lens or the contact lens solution used in this study;
- •A clinical finding or history of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report;
- •Employee of investigational clinic (e.g., Investigator, Coordinator, Technician);
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment;
- •Any slit lamp findings which would contraindicate contact lens wear;
- •Any history of a contact lens-related corneal inflammatory event within the past 12 months that may contraindicate contact lens wear; or
- •Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures;
- •Subjects are considered ineligible for the study as judged by the investigator.
结局指标
主要结局
Permanent loss of visual acuity
时间窗: 13 weeks
The primary safety endpoint in this evaluation is the percentage of subjects with permanent loss of two or more lines of visual acuity.
Serious adverse reactions
时间窗: 13 weeks
The primary safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations.
Best-corrected contact lens visual acuity
时间窗: 13 weeks
The primary efficacy endpoint in this evaluation is the percentage of subjects with best-corrected contact lens visual acuity of 0.8 decimal (+0.10 logMAR) and 1.0 decimal (0.00 logMAR) or better. The Snellen chart will be used for visual acuity testing.
次要结局
- Lens comfort(13 weeks)
- Symptoms of dryness(13 weeks)
- Slit lamp findings(13 weeks)
- Subject reported ocular complaints(13 weeks)