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临床试验/NCT02951910
NCT02951910已完成4 期

A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye

Semmelweis University0 个研究点目标入组 20 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
20
主要终点
Change in OSDI (Ocular Surface Disease Index) score

研究概览

简要总结

Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can already be found in several artificial tears recommended to alleviate symptoms of dry eye. A recent hyaluronate modification involves zinc-hyaluronate complex formation by adding zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular structure, which functions as both a mechanical barrier and a biocompatible film on the ocular surface. Apart from its beneficial elastoviscous characteristics, previous results indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor endings underlying pain. Although hyaluronate is widely used in artificial tears to improve tear film stability, its effect on ocular surface sensitivity was not evaluated in patients with dry eye. The aim of this study is to investigate the characteristics of ocular surface sensations and corneal sensitivity in dry eye patients before and after long-term tear supplementation with zinc-hyaluronate.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had been diagnosed as having dry eye symptoms for at least 3 months, with an OSDI score of ≥13 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI)

排除标准

  • Subjects with ophthalmic conditions other than dry eye or systemic disease including blepharitis, meibomitis, lid abnormalities as well as contact lens wearers

结局指标

主要结局

Change in OSDI (Ocular Surface Disease Index) score

时间窗: 1 month

The change in OSDI (Ocular Surface Disease Index) score will be assessed using the specific OSDI questionnaire

次要结局

  • Change in corneal sensitivity to selective stimulation(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kovács Illés

Assistant professor of Ophthalmology

Semmelweis University

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