A Comparison of Two Daily Disposable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Subjective Overall Vision
研究概览
简要总结
Approximately 120 subjects will be comparing two soft contact lenses for one week each.
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 39 Years（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 be appear able and willing to adhere to instruction set forth in this clinical protocol.
- •The subject be between (and including) 18 and 39 years of age.
- •The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
排除标准
- •Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any autoimmune disease or use of any medication, which may interfere with contact lens wear.
- •Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- •Any previous, or planned ocular or intraocular 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 classification scale, any previous history or signs of a contact lens-related inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular abnormality that may contraindicate contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Monovision, multifocal, toric, or extended wear contact lens correction.
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.
研究组 & 干预措施
senofilcon A/ delefilcon A/ senofilcon A
Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
干预措施: senofilcon A (Device)
senofilcon A/ delefilcon A/ senofilcon A
Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
干预措施: delefilcon A (Device)
delefilcon A/senofilcon A/ delfilcon A
Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third.
干预措施: senofilcon A (Device)
delefilcon A/senofilcon A/ delfilcon A
Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third.
干预措施: delefilcon A (Device)
结局指标
主要结局
Subjective Overall Vision
时间窗: 1-week Follow-up
Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). 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.
Subjective Overall Comfort
时间窗: 1-week Follow-up
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.
次要结局
未报告次要终点