Clinical Evaluation of Etafilcon A With Ketotifen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 12
- 主要终点
- Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population)
研究概览
简要总结
This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Between 18 and 39 (inclusive) years of age at the time of baseline visit.
- •The subject must be a habitual lens wearer for a least 6 days/week and for a minimum of 8 hours per day over the last month.
- •The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
- •The subject's refractive cylinder must be 1.00 D or less in each eye.
- •Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating.
- •Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- •Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear, history of strabismus, or current monovision, multi-focal, or toric contact lens correction.
- •Any current use of rewetting drops or ocular medication.
- •Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, 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 Biomicroscopy 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 would contraindicate contact lens wear.
- •Any known hypersensitivity or allergic reaction to ketotifen.
- •Participation in any eye drop, contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
结局指标
主要结局
Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population)
时间窗: Baseline (Visit 1) and 1-week follow up (Visit 2)
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population)
时间窗: Baseline (Visit 1) and 1-week follow up (Visit 2)
Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.
次要结局
- The Number of Eyes With Clinically Significant Slit Lamp Findings(Up to 1-Week Follow-up)
- The Number of Eyes With Unacceptable Lens Fitting(Up to 1-Week Follow-up)