NL-OMON36552招募中4 期
protocol C-10-017: 'Lens Wearing Experience and Biocompatibility of a Marketed MPDS in Silicone Hydrogel and Soft Contact Lens Wearers' - Marketed MPDS in Contact Lens Wearers
Alcon Laboratories0 个研究点目标入组 78 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.Subjects must be 18 years of age and may be of any race and either gender
- •2.Subjects must wear silicone hydrogel or traditional soft contact lenses on a daily wear basis (minimum of 8 hours per day) for at least 1 month prior to Visit 1
- •3.Subjects must have habitually used a PHMB multi-purpose solution for at least 30 days prior to Visit 1
- •4.Subjects' vision must be correctable to 20/30 (Snellen) or better in each eye at distance with pre-study lenses at Visit 1
- •5. The IRB approved informed consent must be read, signed and dated by the subject or legally authorized representative before enrollment.
- •6.Subjects must be generally healthy and have normal ocular health and willing to follow the study procedures and visit schedule.
- •7. Subjects must be willing to follow the study procedures and visit schedule.
排除标准
- •1.Subjects who need to wear lenses on an extended wear basis during the study.
- •2.Subjects with a known sensitivity or intolerance to PHMB, POLYQUAD, or ALDOX preserved lens care products
- •3.Monocular subjects or subjects fit with only one lens
- •4.Subjects who have used 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
- •5.Subjects must have discontinued the 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
- •6.Any abnormal ocular condition observed during the visit 1 slit-lamp examination
- •7.Current or history of ocular infections or severe inflammation within 6 months prior to visit 1
- •8.current or history of blepharitis that required treatment within 6 months priot to visit 1
- •9.Conjunctival or structural lid abnormalities at visit 1
- •10.Abnormal corneal opacities or significant lenticular inclusions as observed with a slit-lamp at visit 1
- •11.Ocular surgery within 12 months prior to visit 1
- •12.Tarsal abnormalities within 6 months prior to visit 1
- •13.Use of any systemic medications, which have known or expected ocular or systemic side effects at visit 1, that in the clinical judgement of the investigator, could affect the subject's participation in this study unless they have been on a stable dosing regimen for a minimum of 30 days prior to visit 1.
- •14.Any systemic diseases 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
- •15.The investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals
- •16.Participation in any clinical study within 30 days of visit 1
- •17.More than one member of the same household in this study.
研究者
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