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临床试验/NCT01375582
NCT01375582
已完成
早期 1 期

Objective Evaluation of Ocular Surface Lubricants

University of Rochester1 个研究点 分布在 1 个国家目标入组 20 人2011年6月

概览

阶段
早期 1 期
干预措施
B & L Soothe Lubricant Eye Drops
疾病 / 适应症
Dry Eye
发起方
University of Rochester
入组人数
20
试验地点
1
主要终点
Tear Film Properties
状态
已完成
最后更新
3年前

概览

简要总结

This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

详细描述

This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control). The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.

注册库
clinicaltrials.gov
开始日期
2011年6月
结束日期
2012年6月
最后更新
3年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

James V. Aquavella, MD

Principal Investigator

University of Rochester

入排标准

入选标准

  • Age 30-75 years
  • Good general health
  • Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
  • Currently using an OTC artificial tear for ocular comfort, at least occasionally.
  • At least one positive dry eye symptom.

排除标准

  • Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
  • Recent past eye surgery.
  • Female subjects may not be pregnant or lactating.
  • Infectious diseases

研究组 & 干预措施

Drop Administration

干预措施: B & L Soothe Lubricant Eye Drops

Drop Administration

干预措施: Liposic EDO

Drop Administration

干预措施: OcuFresh Eye Wash

结局指标

主要结局

Tear Film Properties

时间窗: Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.

The wavefront sensor instrument measures the eye's ability to create a sharp image. Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea. A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes. A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.

研究点 (1)

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