Evaluation of a New Method for Instilling Eye Drops
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
The purpose of this project is to demonstrate that there is a new easier method to instill eye drops in ones own eye that is as effective as applying a drop directly to their open eye. The benefits of this new method include better medication compliance and reduced patient anxiety from instilling their eye drops. This secondary benefit should remove the "approach-avoidance response" that prompts some patients to delay or give-up on instilling their drops just to avoid the angst and frustration produced by the challenge.
The new method involves the patient instilling the eye drop onto their closed eyelid and then blinking the eye drop into their eye. We aim to show that this method has a similar therapeutic effect as the routine administration of an eye drop to an open eye.
详细描述
PURPOSE:
The purpose of this project is to test an alternative method for instilling eye drops. The new method involves the patient self-administer the eye drop onto the skin of their medial canthus, with the lids gently closed, and then open the lids once the "cold and wet" sensation of the eye drop is felt along the margins of the closed lids. We will compare the physiological and therapeutic efficacy of instilling the same eye drops into the eyes of the same subjects, using two methods. The first will be to have the eye drop administered using the "gold standard" method employed by optometrists to instill eye drops in the office. The second will be to employ the new method of self-administration described above.
HYPOTHESIS:
Instillation of an eye drop, over the gently closed lids at the medial canthus, has the same physiological effect and therapeutic efficacy as a drop of the same agent, at the same concentration, properly applied onto an open eye by a trained professional.
Aim #1: Determine if there is a difference in efficacy between drops of 0.5% timolol maleate administered by a professional, using the standard clinical method versus patient self-administration using the newly proposed method, in NORMAL SUBJECTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both male and female participants are being studied
- •minimum age of 21 and maximum age of 80
- •healthy volunteers with no previous history of eye disease
排除标准
- •no medical conditions representing contraindications to use of topical beta-blocker.
- •subject must not have any active inflammatory diseases of the eye, or have a diagnosis of any form of glaucoma
- •Inclusion Criteria:
- •both male and female participants are being studied
- •minimum age of 21 and maximum age of 80
- •subjects have been diagnosed with primary open angle glaucoma and are stable on monotherapy
- •Exclusion Criteria:
- •Subjects must have no other ocular disease, or a history of prior ocular trauma, beyond minor corneal abrasion or removal of a superficial corneal foreign body.
研究组 & 干预措施
Professional Administration
Instillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) administered by a professional, using the standard clinical method.
干预措施: Timolol maleate 0.5% ophthalmic solution (Drug)
Self-Administration (new method)
Instillation of Timolol maleate 0.5% ophthalmic solution (or participant's own glaucoma medication) self-administered by the participant, using the new proposed method.
干预措施: Timolol maleate 0.5% ophthalmic solution (Drug)
结局指标
主要结局
Intraocular Pressure
时间窗: 2 hours
Intraocular Pressure by Goldmann applanation will be measured pre- and 2 hours post timolol maleate 0.5% ophthalmic solution
次要结局
未报告次要终点