Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

Johnson & Johnson Vision Care, Inc.1 个研究点分布在 1 个国家目标入组 21 人开始时间: 2011年10月1日最近更新: 2018年6月19日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Johnson & Johnson Vision Care, Inc.
入组人数: 21
试验地点: 1
主要终点: Corneal Swelling

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
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

•Be of legal age (i.e. 18 years)
•Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)
•Be mentally competent, willing and able to sign a written informed consent form.
•Have contact lens distance sphere requirement in the range 1.00D to 6.00D.
•Have spectacle astigmatism <1.25D in each eye
•Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications
•Have had an oculo-visual examination within the previous 12 months.
•Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
•No evidence of lid abnormality or infection
•No conjunctival abnormality or infection
•No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
•No other active ocular disease

排除标准

•Requires concurrent ocular medication.
•Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
•Has had refractive surgery.
•Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
•History of abnormal lachrymal secretions.
•Pre-existing ocular irritation that would preclude contact lens fitting.
•Keratoconus or other corneal irregularity.
•Extended lens wear in last 3 months.
•PMMA, hybrid or RGP lens wear in the previous 8 weeks
•Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
•Has diabetes
•Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
•History of chronic eye disease (e.g. glaucoma or ARMD).
•Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
•Participation in any concurrent clinical trial or in last 30 days.
•Family member or employee of the clinical site, investigator or other study staff.
•Currently wears habitual contact lenses on an EW basis.