ACTRN12624000762550尚未招募Unknown
Assessment of tear stability and comfort response when wearing (O-acyl)-hydroxy fatty acids laden daily disposable contact lenses in habitual contact lens wearers aged 18-45 years
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years(—)
- 性别
- All
入选标准
- •Aged 18-45 years old (inclusive)
- •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
- •Habitual contact lens wearer
- •Spherical refractive error between -0.50 to -7.50D or +0.50 to +1.75D (inclusive), with < 1.00 DC (cylinder power)
- •Able to achieve a minimum 6/9.5 binocular visual acuity while wearing the study lenses (with over-spectacles if required)
- •Willing to wear the study contact lenses for a minimum of 8 hours per day.
- •Willing to refrain from wearing their habitual contact lenses for a minimum of 24 hours prior to each visit
- •Have health and ocular health findings which would not prevent the participant from safely wearing contact lenses
- •Willing to not use any rewetting eye drops on the morning of study visits and while wearing the study contact lenses
- •Willing to refrain from swimming, showering, and/or sleeping while wearing the study contact lenses
- •Willing to undergo the tests as outlined in the information statement.
排除标准
- •Gas permeable contact lens wearer
- •Any active corneal infection, ocular allergies
- •Recent or short-term inflammation in the front part of the eye
- •Pregnancy (or planning pregnancy), lactating/breast feeding, suffering from the systemic diseases Sjögren’s syndrome, rheumatoid arthritis, systemic lupus erythematosus, diabetes and thyroid eye disease or taking the medications atropine, antazoline, azatadine or antihistamines such as cetirizine, brompheniramine
- •People who have undergone refractive surgery
- •People with epilepsy
研究者
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