Dispensing Evaluation of Investigational Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 12
- 主要终点
- The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
研究概览
简要总结
Non-randomized, single-masked, 2-visit, bilateral wear, single-arm dispensing study to evaluate the visual acuity, rotational performance, lens fit, stability and subjective characteristics of a senofilcon-based JJVCI investigational toric contact lens design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males or females that are ≥18 years of age and ≤39 years of age.
- •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.
- •The subject must be a habitual toric contact lens wearer. Habitual wearer is defined as someone who wears toric lenses for at least 6 hours a day, 5 days a week for the past 30 days.
- •Subject's vertex corrected spherical component of their distance refraction must be between -1.50 Diopters Sphere (DS) to -4.00 DS (inclusive) in each eye.
- •Subject's vertex corrected refractive cylinder must be between -0.75 and -1.50 Diopters Cylinder (DC) (inclusive) in each eye.
- •Subject's refractive cylinder axis must be within 180±15° and 90±15° in each eye.
- •If needed, the subject must have a wearable pair of spectacles with 20/30 or better vision Ocular Uterque (OU). If spectacles are not needed, the subject must have 20/40 or better vision OU without correction.
- •Subject's best corrected distance acuity must be 20/25-2 or better in each eye.
排除标准
- •Females who are currently pregnant or lactating.
- •Any ocular or systemic allergies or diseases that may contraindicate contact lens wear.
- •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, Sjogren's syndromes, xerophthalmia, acne rosacea, and/or Stevens-Johnson syndromes, by self-report.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report.
- •Habitual wearer of extended wear contact lenses.
- •Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- •History of seizures.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by report.
- •History of binocular vision abnormality or strabismus, by self-report.
- •Habitual wearer of rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- •Employee and family members of employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA classification scale.
- •Any history of a contact lens-related corneal inflammatory event within the past year that may contraindicate contact lens wear.
- •Any active ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Any fluctuations in vision due to clinically significant dry eye or other ocular conditions.
研究组 & 干预措施
Prototype toric lens senofilcon A
Subjects will wear the senofilcon A prototype toric contact lens bilaterally for 6-8 days as a daily disposable modality.
干预措施: Prototype toric lens senofilcon A (Device)
结局指标
主要结局
The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
时间窗: 15 Minutes Post Insertion
Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.
Proportion of Eyes With Monocular Visual Acuity Better Than 20/40
时间窗: 7 day follow-up
Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.
Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees
时间窗: 15 Minutes Post Insertion
Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.
Proportion of Subject Eyes With Acceptable Lens Fit
时间窗: 15 Minute Post Insertion
Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.
次要结局
未报告次要终点