Lens Wearing Experience and Biocompatibility With OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution (OFP MPDS) in Silicone Hydrogel and Soft Contact Lens Wearers (US)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Corneal Fluorescein Staining Type at Baseline
研究概览
简要总结
The purpose of this study was to evaluate the efficacy of a new multipurpose disinfecting solution in silicone hydrogel and soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Wear silicone hydrogel or traditional soft contact lenses on a daily wear basis, (a minimum of 8 hours per day) for at least one month prior to Visit 1;
- •Habitual use of a multi-purpose solution containing PHMB for at least 30 days prior to Visit 1;
- •Vision correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1;
- •Read, sign, and date IRB-approved informed consent and privacy document;
- •Be generally healthy and have normal ocular health;
- •Willing to follow the study procedures and visit schedule;
- •Other protocol-defined inclusion criteria may apply.
- •Exclusion Criteria
- •Wear lenses on an extended wear basis during the study;
- •Known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products;
- •Monocular subject;
- •Requirestoric or multifocal contact lenses;
- •Use of additional lens care products other than a PHMB multi-purpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
- •Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
- •Any abnormal ocular condition observed during the Visit 1 Slit-lamp examination;
- •Ocular surgery within the 12 months prior to Visit 1;
- •Use of any systemic medication which has known or expected ocular or systemic side effects at Visit 1, that in the clinical judgment of the investigator, could affect the subject's participation in this study;
- •Any systemic disease at Visit 1 that may affect the eye or be exacerabated by use of contact lenses or contact lens solutions or which could prevent subjects from wearing their lenses at least 8 hours per day;
- •Participation in any clinical study within 30 days of Visit 1;
- •Other protocol-defined exclusion criteria may apply.
排除标准
- 未提供
结局指标
主要结局
Corneal Fluorescein Staining Type at Baseline
时间窗: Day 0 (Baseline)
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Corneal Fluorescein Staining Type at Day 30
时间窗: Day 30
Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (\>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.
Corneal Fluorescein Staining Area at Baseline
时间窗: Day 0 (Baseline)
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated \[i.e., 0% (no staining in the region) to 100% (staining covers entire region)\], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
Corneal Fluorescein Staining Area at Day 30
时间窗: Day 30
Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated \[i.e., 0% (no staining in the region) to 100% (staining covers entire region)\], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.
次要结局
未报告次要终点