Clinical and Laboratory Evaluation of Three Contact Lens Materials With Four Contact Lens Solutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 4
- 主要终点
- Overall Comfort Score (Senofilcon A Lens)
研究概览
简要总结
The purpose of this study is to evaluate the clinical and laboratory performance of three brand name contact lenses with three recently introduced multipurpose lens care solutions (test solutions) as well as a peroxide disinfecting solution (control solution).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older 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 instruction set forth in this clinical protocol.
- •The subject must be between 18 and 69 years of age.
- •The subject must be willing to participate in a 9-month study.
- •The subject must require a visual correction in both eyes.
- •Subjective refraction must result in a vertex-corrected spherical contact lens prescription of +2.00D to -8.00D in each eye.
- •The subject must have best-corrected visual acuity of 0.20 or better in each eye.
- •The subject must be a current wearer of spherical soft contact lenses (no bifocal contact lenses or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
- •The subject must require no more than -1.25D cylindrical correction in each eye after vertexing to the corneal plane.
- •The subject must have normal eye with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
排除标准
- •Self-reported current pregnancy or lactation or plans to become pregnant during the study period (subjects who report becoming pregnant during the study will be discontinued).
- •Self-reported adverse reaction to a contact lens solution to be used in the study that in the opinion of the investigator would contraindicate use of that solution.
- •Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- •Any clinically meaningful slit lamp findings contraindicating contact lens wear (e.g. equal to or greater than Grade 3 finding of edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, blepharitis/meibomian gland dysfunction) on the study specific classification scale or any other ocular abnormality that in the opinion of the investigator would contraindicate contact lens wear.
- •Any active ocular infection.
- •Current use of topical ophthalmic medications.
- •History of binocular vision abnormality or strabismus.
- •More than occasional use of dry eye/rewetting drops (more than 2 times per day on average).
- •Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
- •History of severe allergic reaction or anaphylaxis.
- •Other active ocular disease that in the opinion of the investigator would contraindicate contact lens wear.
- •Employee of the investigational clinic (e.g. investigator, coordinator, technician)
- •They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
研究组 & 干预措施
Lens A (senofilcon A)
Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 1 (Test) (Other)
Lens A (senofilcon A)
Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 2 (Test) (Other)
Lens A (senofilcon A)
Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 3 (Test) (Other)
Lens A (senofilcon A)
Subjects randomized to Lens A will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 4 (Control) (Other)
Lens B (galyfilcon A)
Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 1 (Test) (Other)
Lens B (galyfilcon A)
Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 2 (Test) (Other)
Lens C (etafilcon A)
Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 2 (Test) (Other)
Lens B (galyfilcon A)
Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 3 (Test) (Other)
Lens B (galyfilcon A)
Subjects randomized to Lens B will be further randomized to 1 of 12 unique solution sequences; each subject will receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 4 (Control) (Other)
Lens C (etafilcon A)
Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 1 (Test) (Other)
Lens C (etafilcon A)
Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 3 (Test) (Other)
Lens C (etafilcon A)
Subjects randomized to Lens C will be further randomized to 1 of 12 unique solution sequences; each subject will l receive all four study solutions in a random order (Solution 1(Test), Solution 2(Test), Solution 3(Test), Solution 4(Control)).
干预措施: Solution 4 (Control) (Other)
结局指标
主要结局
Overall Comfort Score (Senofilcon A Lens)
时间窗: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Overall Comfort Score (Galyfilcon A Lens)
时间窗: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Overall Comfort Score (Etafilcon A Lens)
时间窗: 2-Week Follow-up
CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
次要结局
未报告次要终点