Clinical Performance Evaluation of Two Silicone Hydrogel Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Overall CLUE Comfort
研究概览
简要总结
This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with 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
- Treatment
- 盲法
- Single (Participant)
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 between 18 and 40 years of age.
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye.
- •The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane.
- •The subject must have best corrected visual acuity of 0.20 or better in each eye.
- •The subject must be a current wearer of daily, spherical, soft contact lenses (no 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 be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day.
- •The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.
- •The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
- •The subject must meet normal eligibility conditions of binocular vision tests.
- •The subject may not have any double vision at near with their habitual contact lens correction.
排除标准
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •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).
- •Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion).
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
- •Any active ocular infection.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- •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.
- •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.
- •History of binocular vision abnormality or strabismus.
- •Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
研究组 & 干预措施
Group 1 (TEST / CONTROL wear sequence)
Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
干预措施: CONTROL Contact Lens (Device)
Group 1 (TEST / CONTROL wear sequence)
Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
干预措施: TEST Contact Lens (Device)
Group 2 (CONTROL / TEST wear sequence)
Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
干预措施: TEST Contact Lens (Device)
Group 2 (CONTROL / TEST wear sequence)
Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
干预措施: CONTROL Contact Lens (Device)
结局指标
主要结局
Overall CLUE Comfort
时间窗: Up to 4-Week Follow-up
Overall 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
- Overall CLUE Handling(Up to 4-Week Follow-up)
- Time to Haze(Up to 4-Week Follow-up)
- Average Comfortable Wear Time(Up to 4-Week Follow-up)
- Difference in Total Device Use Time and Comfortable Wear Time During Device Use(Up to 4-Week Follow-up)
- Average Wear Time(Up to 4-Week Follow-up)
- Comfort at the End of the Day(Up to 4-Week Follow-up)