Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Ocular surface residence time
研究概览
简要总结
The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosed with mild to moderate dry eye as defined in the protocol.
- •Able and willing to follow instructions.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any medical condition that may affect the results of the study.
- •History or evidence of ocular or intraocular surgery within the past six months.
- •History of intolerance or hypersensitivity to any component of the study medications.
- •Use of concomitant topical ocular medications during the study period.
- •Ocular conditions that may preclude safe administration of the test article.
- •Unwilling to discontinue contact lens wear during the study period.
- •Participation in an investigational drug or device study within 30 days of enrollment.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Systane, Unisol, Hialid
1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Hialid 0.1 Artificial Tears Eye Drops (Other)
Hialid, Systane, Unisol
1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Systane Ultra Lubricant Eye Drops (Other)
Systane, Hialid, Unisol
1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Hialid 0.1 Artificial Tears Eye Drops (Other)
Systane, Hialid, Unisol
1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Unisol 4 Saline Solution (Other)
Systane, Unisol, Hialid
1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Unisol 4 Saline Solution (Other)
Hialid, Systane, Unisol
1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Hialid 0.1 Artificial Tears Eye Drops (Other)
Hialid, Systane, Unisol
1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Unisol 4 Saline Solution (Other)
Hialid, Unisol, Systane
1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Hialid 0.1 Artificial Tears Eye Drops (Other)
Hialid, Unisol, Systane
1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Unisol 4 Saline Solution (Other)
Unisol, Systane, Hialid
1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Hialid 0.1 Artificial Tears Eye Drops (Other)
Unisol, Systane, Hialid
1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Unisol 4 Saline Solution (Other)
Unisol, Hialid, Systane
1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Hialid 0.1 Artificial Tears Eye Drops (Other)
Unisol, Hialid, Systane
1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Unisol 4 Saline Solution (Other)
Unisol, Hialid, Systane
1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Systane Ultra Lubricant Eye Drops (Other)
Unisol, Systane, Hialid
1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Systane Ultra Lubricant Eye Drops (Other)
Hialid, Unisol, Systane
1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Systane Ultra Lubricant Eye Drops (Other)
Systane, Unisol, Hialid
1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Systane Ultra Lubricant Eye Drops (Other)
Systane, Hialid, Unisol
1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit.
干预措施: Systane Ultra Lubricant Eye Drops (Other)
结局指标
主要结局
Ocular surface residence time
时间窗: Time to event
Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer.
次要结局
未报告次要终点