Quantifying Ocular Surface Aberrations After Tear Film Interventions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in higher order aberrations with an eye drop
研究概览
简要总结
The CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are at least 17 years of age and have full legal capacity to volunteer.
- •Have signed the information consent letter.
- •Are willing and able to follow instructions and maintain the appointment schedule.
- •Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
- •Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.
- •Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye.
- •Agree to wear the study contact lenses for at least 6 hours.
- •Have clear corneas (e.g. no central scars).
- •Have no active ocular disease or inflammation.
排除标准
- •Are participating in another concurrent clinical research study.
- •Have worn any rigid contact lenses in the past 30 days.
- •Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
- •Have any known active ocular condition, disease, and/or infection.*
- •Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.
- •Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study.
- •Have undergone refractive error surgery.
- •Are a member of the study team for this study, i.e. are listed on the delegation log for this study.
研究组 & 干预措施
Experimental: Systane Complete/ Somofilcon A/ Senofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.
干预措施: Somofilcon A (Device)
Experimental: Systane Complete / Senofilcon A/ Somofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.
干预措施: Systane Complete Preservative-Free (Drug)
Experimental: Systane Complete / Senofilcon A/ Somofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.
干预措施: Senofilcon A (Device)
Experimental: Systane Complete / Senofilcon A/ Somofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.
干预措施: Somofilcon A (Device)
Experimental: Systane Complete/ Somofilcon A/ Senofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.
干预措施: Systane Complete Preservative-Free (Drug)
Experimental: Systane Complete/ Somofilcon A/ Senofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.
干预措施: Senofilcon A (Device)
结局指标
主要结局
Change in higher order aberrations with an eye drop
时间窗: Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Change in higher order aberrations with senofilcon A
时间窗: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Change in higher order aberrations with somofilcon A
时间窗: Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
次要结局
未报告次要终点