Optive Brand For Day And Night Dry Eye Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Measured Lissamine Green Bulbar Conjunctival Staining (mm2)
研究概览
简要总结
This is an open label study of Optive eyedrops and gel combination for day and night dry eye management
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
- •OSDI score of ≥ 23
- •Ocular comfort at waking <65 on 100-point scale
- •Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye
- •Use of eyedrops for the relief of dry eye symptoms for at least one month
- •Best corrected visual acuity in each eye of at least 20/25
- •Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study
- •Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
排除标准
- •Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month
- •Use of Optive brand eyedrops in the last month
- •Monocular participants (only one eye with functional vision).
- •Contact lens wear during the study
- •History of herpetic keratitis, ocular surgery or irregular cornea;
- •Known pregnancy or lactation during the study period
- •Participation in any clinical trial within 30 days of the enrollment visit
研究组 & 干预措施
Optive® Fusion + Optive® Gel Drop
Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep. The treatment regimen will be used for one month.
干预措施: Optive® Fusion + Optive® Gel Drop (Device)
结局指标
主要结局
Measured Lissamine Green Bulbar Conjunctival Staining (mm2)
时间窗: Change from baseline to (day 30 +/- 3 days)
The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2).
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
时间窗: Change from baseline to (day 30 +/- 3 days)
A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.
次要结局
- Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking(Baseline (day 0) to (day 30 +/- 3 days))