A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 17
- 主要终点
- Overall Comfort
研究概览
简要总结
This study is to evaluate the safety and effectiveness of ABT12 Multi-Purpose solution (Test) compared to COMPLETE® Multi-Purpose Solution Easy Rub® Formula ("COMPLETE Multi-Purpose Solution") when used by participants who are habitual contact lens wearers.
详细描述
Eligible participants will be enrolled from 1 of 5 lens groups based on their habitual contact lenses. Participants will be randomized on a 1:1 basis within each group per site to receive either ABT12 Multi-Purpose solution or COMPLETE Multi-Purpose Solution. The 5 lens groups will be comprised of habitual wearers of soft lenses based on the following lens material:
- Etaficon A, Acuvue2, Vistakon
- Balafilcon A, PureVision2, Bausch + Lomb
- Samfilcon A, Ultra, Bausch + Lomb
- Lotrafilcon B, Optix Aqua, Alcon
- Senofilcon C, Vita, Vistakon
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate local privacy regulations
- •Is a habitual wearer (at least 3 months) of one of the following lens types: 1) Etaficon A, Acuvue2, Vistakon; 2) Balafilcon A, PureVision2, Bausch + Lomb; 3) Samfilcon A, Ultra, Bausch + Lomb; 4) Lotrafilcon B, Optix Aqua, Alcon; 5) Senofilcon C, Vita, Vistakon
- •Vision is correctable through spherocylindrical refraction to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (distance, high contrast) in each eye with soft spherical contact lenses
- •Has clear central corneas and is free of any anterior segment disorders
- •Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
- •Requires lens correction in both eyes
- •Wears the same manufacturer and brand of lens in both eyes
- •Agrees to wear study lenses on a daily wear basis for approximately 3 months
- •Is willing and able to comply with all treatment and follow-up/study procedures
排除标准
- •Participants who currently use a hydrogen-peroxide cleaning and disinfecting solution
- •Participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation
- •Females of childbearing potential (those who are not surgically sterilized or postmenopausal), if they are currently pregnant, plan to become pregnant during the study, or are breastfeeding
- •Has worn gas permeable (GP) lenses within the last 30 days.
- •Has worn polymethylmethacrylate (PMMA) lenses within the last 3 months
- •Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study
- •Has any ocular disease or is using any ocular medication
- •Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance
- •Currently wears monovision, multifocal, or toric contact lenses
- •Has ocular astigmatism of 1.00 diopter (D) or greater in either eye
- •Vision is not correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses
- •Has anisometropia (spherical equivalent) of greater than 2.00D
- •Has any Grade 2 or greater finding during the slit lamp examination
- •Has corneal infiltrates, of any grade
- •Participants with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
- •Has any scar or neovascularization within the central 6 millimeters (mm) of the cornea. Note that participants with minor peripheral corneal scarring (that does not extend into the central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study
- •Is aphakic
- •Is amblyopic
- •Has had any corneal surgery (for example, refractive surgery)
- •Is allergic to any component in the study care products
- •Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household
- •Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties
- •Is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, or Johnson & Johnson) or currently resides with a person employed by any of these manufacturers
研究组 & 干预措施
COMPLETE Multi-Purpose Solution
Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.
干预措施: Sensitive Eyes® Rewetting Drops (Device)
ABT12 Multi-Purpose Solution
Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.
干预措施: ABT12 Multi-Purpose Solution (Device)
ABT12 Multi-Purpose Solution
Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.
干预措施: Sensitive Eyes® Rewetting Drops (Device)
COMPLETE Multi-Purpose Solution
Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.
干预措施: COMPLETE Multi-Purpose Solution (Device)
结局指标
主要结局
Overall Comfort
时间窗: Month 3
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Eye Dryness
时间窗: Month 3
Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.
Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings
时间窗: Day 0 (post-dispensing) through Month 3
Graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Greater than Grade 2 findings (Absent, Present) will be summarized at the eye level by treatment. Grades are 0(none), 1 (Trace), 2 (Mild), 3 (moderate), 4 (severe)
Degree Of Lens Deposits
时间窗: Month 3
Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.
次要结局
未报告次要终点