A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
研究概览
简要总结
The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
详细描述
Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Sign Informed Consent.
- •Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
- •At least a 3 month documented history of dry eye in both eyes.
- •TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Pregnant or breastfeeding.
- •Any evidence of ocular infection or inflammation within 30 days prior to Screening.
- •Any ocular surgery.
- •Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
- •Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
- •Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
- •Participation in any other clinical trial within 30 days prior to Screening.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
FID 119515A
FID 119515A, 1 drop instilled in the study eye, single dose
干预措施: FID 119515A (Other)
Blink
Blink® Tears, 1 drop instilled in the study eye, single dose
干预措施: Blink® Tears (Other)
结局指标
主要结局
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
时间窗: Baseline, 60 minutes
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
次要结局
- Area Under Curve (AUC) of TBUT From 0 to 60 Minutes(0 to 60 minutes)