Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 20
- 主要终点
- Overall Comfort (Phase I)
研究概览
简要总结
This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-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
- 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:
- •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.
- •Be between 18 and 40 (inclusive) years of age at the time of screening.
- •By self-report, habitually wear soft spherical contact lenses in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
- •By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week.
- •The vertex-corrected best spherical distance refraction (rounded to nearest 0.25 D) must be between -1.00 and -4.00 DS (inclusive) in each eye.
- •The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Be currently pregnant or breastfeeding
- •By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
- •Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
- •Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
- •Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
- •Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
- •Have a history of amblyopia or strabismus.
- •Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months.
- •Have clinically significant (Grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- •Have any ocular infection.
结局指标
主要结局
Overall Comfort (Phase I)
时间窗: 1-Week Follow-up
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Comfort (Phase I)
时间窗: 1-Week Follow-up
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Dryness (Phase I)
时间窗: 1-Week Follow-up
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Dryness (Phase II)
时间窗: 1-Week Follow-up
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Overall Comfort (Phase II)
时间窗: 1-Week Follow-up
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Comfort (Phase II)
时间窗: 1-Week Follow-up
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
次要结局
- Comfort While Using Digital Devices (Phase II)(1-Week Follow-up)
- Lens Awareness Upon Insertion (Phase II)(1-Minute Post lens fitting)
- Comfort Upon Insertion (Phase II)(1-Minute Post lens fitting)
- Comfort Throughout the Day (Phase II)(1-Week Follow-up)
- Ease of Removal (Phase II)(1-Week Follow-up)
- Dryness While Using Digital Devices (Phase II)(1-Week Follow-up)
- Overall Ease of Handling (Phase II)(1-Week Follow-up)
- Ease of Insertion (Phase II)(1-Week Follow-up)