Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution in Gas Permeable Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Percentage of Subjects With Film Deposits by Type
研究概览
简要总结
The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.
详细描述
Subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal eyes (other than correction for visual acuity);
- •Successful history of gas permeable contact lens wear in both eyes in one of two brands: Boston XO or Boston II;
- •Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
- •Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
- •Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
- •History of intolerance or hypersensitivity to any component of the investigational products;
- •Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
- •Moderate, severe, abnormal, or other ocular findings;
- •Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
- •Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
- •Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
- •Ocular surgery within the last 12 months;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percentage of Subjects With Film Deposits by Type
时间窗: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Average Lens Wear Time
时间窗: Day 7, Day 30, Day 60, Day 90
Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.
Percentage of Subjects With Visibly Clean Lenses
时间窗: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.
Average Residual Lens Lysozyme
时间窗: Day 90/Early Exit
Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
时间窗: Baseline (Day 0), Day 7, Day 30, Day 60, Day 90
Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
Percentage of Subjects With Crystalline Deposits by Type
时间窗: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Number of Unscheduled Lens Replacements by Reason
时间窗: Up to Day 90
No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
时间窗: Day 7, Day 30, Day 60, Day 90
Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
时间窗: Day 7, Day 30, Day 60, Day 90
Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Crystalline Deposit Area Covered
时间窗: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
时间窗: Day 7, Day 30, Day 60, Day 90
Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Film Deposit Area Covered
时间窗: Day 7, Day 30, Day 60, Day 90
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
次要结局
未报告次要终点