Investigation of Maintaining Visual Performance Achieved With Cyclosporine Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 40
- 主要终点
- Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye
研究概览
简要总结
This study will evaluate the safety and efficacy of cyclosporine 0.05% ophthalmic emulsion (Restasis®) in patients with dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •History of dry eye in both eyes
- •Willing to use eye drops for dry eye symptoms
排除标准
- •Anticipate wearing contact lenses during the study
- •Laser-assisted in situ keratomileusis (LASIK) surgery within the past 12 months
- •Any ocular and/or lid surgeries within the past 6 months
- •Cataract surgery in either eye
- •Current or anticipated use of temporary punctal plugs during the study
研究组 & 干预措施
cyclosporine 0.05% ophthalmic emulsion
Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
干预措施: carboxymethylcellulose-based lubricant eye drops (Drug)
cyclosporine 0.05% ophthalmic emulsion
Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
干预措施: cyclosporine 0.05% ophthalmic emulsion (Drug)
结局指标
主要结局
Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye
时间窗: Baseline, Month 6
Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Driving at Night on the OSDI
时间窗: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye
时间窗: Baseline, Month 6
Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
时间窗: Baseline, Month 6
Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye
时间窗: Baseline, Month 6
Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).
Change From Baseline in Working With a Computer or Bank Machine on the OSDI
时间窗: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Reading Rate
时间窗: Baseline, Month 6
Reading speed is assessed as the number of words read correctly in 2 minutes.
Change From Baseline in Words Read Incorrectly
时间窗: Baseline, Month 6
The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.
Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)
时间窗: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Watching TV on the OSDI
时间窗: Baseline, Month 6
The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.
Change From Baseline in Font Size
时间窗: Baseline, Month 6
The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
次要结局
- Change From Baseline in Ocular Discomfort on a 4-point Scale(Baseline, Month 6)
- Change From Baseline in Tear Film Break-up Time in the Worse Eye(Baseline, Month 6)
- Change From Baseline in OSDI(Baseline, Month 6)
- Change From Baseline in the Interblink Interval in the Worse Eye(Baseline, Month 6)
- Change From Baseline in Conjunctival Redness in the Worse Eye(Baseline, Month 6)