Initial Evaluation of Investigational Lenses Manufactured on a New Production Line
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 12
- 主要终点
- Distance Monocular LogMAR Visual Acuity
研究概览
简要总结
This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6 hours per day and 5 days per week for approximately two weeks each. The subject will wear either the Test or Control lens twice and the other study lens once.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must read and sign the Informed Consent form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
- •The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and -6.00 D.
- •The subject's refractive cylinder must be ≤ 1.00 D in each eye.
- •The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- •Subjects must own a wearable pair of spectacles.
- •The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
- •Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- •Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- •Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.).
- •Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- •Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
- •Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Toric, extended wear, monovision or multi-focal contact lens correction.
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- •Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
结局指标
主要结局
Distance Monocular LogMAR Visual Acuity
时间窗: 2-Week Follow-up
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination \> 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination \<2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.
Contact Lens Fitting Acceptance Rate
时间窗: Up to 2-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.
Number of Grade 3 or Higher Slit Lamp Findings
时间窗: Up to 2-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.
Overall Comfort Score
时间窗: 2-Week Follow-up
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Vision Satisfaction in Bright Lighting
时间窗: 2-Week Follow-up
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type.
次要结局
- Overall Quality of Vision Score(2-Week Follow-up)
- Overall Handling Scores(2-Week Follow-up)
- Overall Quality of Vision Indoors(2-Week Follow-up)