Evaluation of Three Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Overall Comfort
研究概览
简要总结
This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •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 willing and able to follow instructions and maintain the appointment schedule;
- •The subject must be between the age of 18 and 40 years (inclusive);
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive);
- •The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane;
- •The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye;
- •The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment;
- •The subject must own a wearable pair of spectacles and wear them the day of the initial visit;
- •The subject must be an existing wearer of spherical, soft contact lenses in both eyes;
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type);
- •The subject must be willing to wear the study lenses for a minimum eight hours per day.
排除标准
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion);
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion);
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued);
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease;
- •Any active ocular infection;
- •Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit;
- •Any participants whose habitual contact lenses are used as an extended wear regimen;
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry;
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.);
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; or clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear;
- •Any known hypersensitivity or allergic reaction to the study products;
- •Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment;
- •Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).
研究组 & 干预措施
Lens 2/ Lens 3/ Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third .
干预措施: Lens 2 (nelfilcon A) (Device)
Lens 1/ Lens 2/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third.
干预措施: Lens 1 (etafilcon A) (Device)
Lens 1/ Lens 2/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third.
干预措施: Lens 2 (nelfilcon A) (Device)
Lens 1/ Lens 2/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (nesofilcon A) third.
干预措施: Lens 3 (nesofilcon A) (Device)
Lens 1 / Lens 3 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third.
干预措施: Lens 1 (etafilcon A) (Device)
Lens 1 / Lens 3 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third.
干预措施: Lens 2 (nelfilcon A) (Device)
Lens 1 / Lens 3 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 1 (etafilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 2 (nelfilcon A) third.
干预措施: Lens 3 (nesofilcon A) (Device)
Lens 2/ Lens 3/ Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third .
干预措施: Lens 1 (etafilcon A) (Device)
Lens 2/ Lens 3/ Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 3 (nesofilcon A) second and then wear Lens 1 (etafilcon A) third .
干预措施: Lens 3 (nesofilcon A) (Device)
Lens 2 / Lens 1/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
干预措施: Lens 1 (etafilcon A) (Device)
Lens 2 / Lens 1/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
干预措施: Lens 2 (nelfilcon A) (Device)
Lens 2 / Lens 1/ Lens 3
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 2 (nelfilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nesofilcon A) third. Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
干预措施: Lens 3 (nesofilcon A) (Device)
Lens 3 / Lens 1 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third.
干预措施: Lens 1 (etafilcon A) (Device)
Lens 3 / Lens 1 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third.
干预措施: Lens 2 (nelfilcon A) (Device)
Lens 3 / Lens 1 / Lens 2
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 1 (etafilcon A) second and then wear Lens 3 (nelfilcon A) third.
干预措施: Lens 3 (nesofilcon A) (Device)
Lens 3 / Lens 2 / Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third.
干预措施: Lens 1 (etafilcon A) (Device)
Lens 3 / Lens 2 / Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third.
干预措施: Lens 2 (nelfilcon A) (Device)
Lens 3 / Lens 2 / Lens 1
Each subject will be randomly assigned to one of six unique sequences. Subjects randomized to this sequence will first wear Lens 3 (nesofilcon A), then wear Lens 2 (nelfilcon A) second and then wear Lens 3 (etafilcon A) third.
干预措施: Lens 3 (nesofilcon A) (Device)
结局指标
主要结局
Overall Comfort
时间窗: 2- Week Follow-up
Clue 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.
次要结局
未报告次要终点