An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days
研究概览
简要总结
To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.
详细描述
This is a Non-Significant Risk (NSR) medical device, multi-center, open-label clinical study. Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion.
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
- 是
入选标准
- •A male or female subject, 18 years of age or older, in good general health at the time of the baseline examination, who may or may not have a mild to moderate dry eye condition
- •A subject must be able to read, comprehend and be willing to give HIPAA authorization and informed consent
- •A subject must be willing to have a punctal plug inserted in the lower punctum of one of their eyes
- •A subject must be willing to comply with all study instructions, agree to make all office appointments, and complete the entire course of the study
排除标准
- •A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in the planned study eye
- •A subject with a history of intolerance to punctal plugs
- •A subject with structural lid abnormalities (e.g., ectropion, entropion) in the planned study eye
- •A subject with any clinically significant lid, conjunctival or corneal findings in the planned study eye at the baseline visit
- •A subject with a severe dry eye condition
- •A subject experiencing epiphora in the planned study eye
- •A subject experiencing any clinically significant ocular pain or discomfort in or around either eye at the baseline visit
研究组 & 干预措施
NDE L68 StableFit® punctal plug
Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion
干预措施: NDE L68 StableFit® Punctal Plug (Device)
结局指标
主要结局
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days
时间窗: 7 days
The primary study endpoint will be the comparison of the tear lake volume at baseline with the tear lake volume at each follow-up visit. The tear lake will be evaluated using a slit lamp micrometer, the micrometer will be oriented vertically and centered on the lower lid margin at the middle of the lower lid. The tear lake will be measured using the slit lamp micrometer from the lid margin to the superior border of the lower tear lake and measured to 0.1 mm. The average mean percent change from baseline tear lake volume was compared to that at 7 days.
Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days
时间窗: 28 days
The primary study endpoint will be the comparison of the tear lake volume at baseline with the tear lake volume at each follow-up visit. The tear lake will be evaluated using a slit lamp micrometer, the micrometer will be oriented vertically and centered on the lower lid margin at the middle of the lower lid. The tear lake will be measured using the slit lamp micrometer from the lid margin to the superior border of the lower tear lake and measured to 0.1 mm. The average mean percent change from baseline tear lake volume was compared to that at 28 days.
次要结局
- Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days(28 days)