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临床试验/NCT03617315
NCT03617315已完成不适用

Crosslinked Hyaluronic Acid With Liposomes and Crocin in the Treatment of Dry Eye Disease Due to Moderate Meibomian Glands Dysfunction

University of Seville1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Schirmer Test

研究概览

简要总结

A total of 50 eyes were analyzed (25 patients). The subjects selected were over 18 years of age. No gender distinction was made in the choice of subjects. All subjects were carriers of silicone hydrogel contact lenses. The antecedents of the eye diseases not identified, neither the previous eye surgeries nor the systemic or ocular medication. All patients read, understood and signed an informed consent form of the study.

详细描述

A study was performed using the contralateral eye, the study groups were randomized. The choice of eye for each tear was random and established as an artificial tear A and artificial tear B. The patients were not previously warned about the type of artificial tear they were going to use or the difference that existed between them, therefore, they were unaware of the benefits that such tears could offer them. The examiner did know what tear was applied to each eye.

As for the lubricants used; Tear A (Aquoral Forte®, ESTEVE®, Farmigea, Pisa, Italy) was a combination of 0.4% unridged hyaluronic acid and 0.2% Galacto-xyloglucan. The galacto-xyloglucan is extracted from the tamarind seed. It consists of 30 single doses, each with 0.5 ml and have a daily use closure, that is, it can not be used once 12 hours have passed since the dose was opened. This lubricant lacks preservatives.

On the other hand, tear B (Aquoral Lipo® [Spain] / Lumixa® [Italy], ESTEVE®, Farmigea, Pisa, Italy) is a combination of three components; cross-linked hyaluronic acid (CXL) at 0.15%, crocin and liposomes. It is an ophthalmic lubricant and antioxidant solution. Its package is 10 ml multidose, so it can be used for a long time. It is composed of liposomes, sodium salt of crosslinked hyaluronic acid 0.15%, ethylenediaminetetraacetic acid (EDTA) disodium salt and crocin. Although this tear comes in a multi-dose container, it does not contain a preservative due to the dispenser that does not let microorganisms from outside. Contact lenses can be used while both lubricants are applied. In this regard, the study patients used their silicone hydrogel contact lenses monthly during the study.

All patients in the study had a period of one month without using any type of artificial tear or eye drops. Once this time or study was over, the patients were explained how artificial tears should be instilled. The visits were carried out blindly by research optometrists. Who did not know how the distribution of artificial tears in patients had been. The artificial tears were administered 3 times a day for 6 weeks and the subjects belonging to the study underwent a clinical examination in the period prior to treatment and 45 days after the treatment, once the treatment with artificial tears. He was repeated the tests of the beginning, nevertheless, the meibografía was not realized, since the use of artificial tears was not going to cause the growth of the glands of Meibomio

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
Double (Participant, Outcomes Assessor)

盲法说明

The patients did not know the artificial tear that should be applied. The researcher in charge of processing the results and drawing the conclusions did not know the name of the artificial tears

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ocular Surface Disease Index over 15
  • Dysfunction of the meibomian gland
  • User contact lenses silicone hydrogel
  • User of digital screens for a long timeç

排除标准

  • Previous eye surgeries
  • Previous eye pathologies
  • User of artificial tears
  • User of ophthalmic gels

研究组 & 干预措施

Hyaluronic Acid

Experimental

One drop application of Hyaluronic acid + Galact-Xyloglucan with a dosage of 3 times a day for 45 days

干预措施: Hylauronic Acid (Drug)

CrossLinked Hyalurnic Acid

Experimental

One drop application of Crosslinked Hylauronic Acid + Liposomes with a dosage of 3 times a day for 45 days

干预措施: Hylauronic Acid (Drug)

结局指标

主要结局

Schirmer Test

时间窗: 6 weeks

Measurement of the tear volume. Scale between 0 and 30 milimeters (mm) Higger is better

Break Up Time Test

时间窗: 6 weeks

Lacrimal rupture time of the lipid layer. Scale between 0 and 25 seconds (s) Higger is better

Ocular Surface Disease Index

时间窗: 6 weeks

Dry Eye Score from Questionnaire. Scale between 0 and 50 points. Higger is worse

次要结局

未报告次要终点

研究者

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

José-María Sánchez-González

PhD Optometry and Vision Science

University of Seville

研究点 (1)

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