EUCTR2007-005882-37-IT
进行中（未招募）
不适用
RANDOMIZED CONTROLLED CLINICAL STUDY ON THE EFFICACY AND TOLERABILITY OF 0.4% HYALURONIC ACID HYPOTONIC EYE DROPS (IALUREX) VS. HYDROXYPROPYL-GUAR EYE DROPS (SYSTANE) IN THE TREATMENT OF DRY EYE SYNDROME - ND
BAUSCH&LOMB0 个研究点2008年10月24日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Dry eye syndrome
- 发起方
- BAUSCH&LOMB
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Legally adult outpatients having given their written informed consent with : 1\. Dry eye syndrome (either hyposecretive or hyperevaporative type) since at least two months. 2\. Schirmer l test\&\#8804;10 mm/5 min. 3\. Positivity to vital corneal staining\&\#8805;3/15 (NEI scheme). 4\. Symptomatology of dry eye with at least two positive symptoms (VAS\>60\) in the preceding 72 hours, out of five: \-burning/stinging sensation, \-ocular discomfort while blinking \-foreign body sensation \-sensation of ocular fatigue/heaviness of the lid \-willingness to keep eyes closed. 5\. Willingness to participate in the study while following the indications
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
排除标准
- •1\.Age \<18 years.
- •2\.Pregnant or lactating women.
- •3\.Women of childbearing potential who are not using adequate contraception methods.
- •4\.Ocular surgery within the last three months.
- •5\.Presence or onset of eye infections or of other acute pathologies which could be resolved or modified during the course of the study independently from the treatment with study drugs.
- •6\.Presence or onset of glaucoma.
- •7\.Using any topical ophthalmic medication with the exception of tear substitutes and/or eye cleaning solutions for the treatment of dry eye.
- •8\.Patients being treated with topical ocular, cyclosporine, steroidal or non steroidal, anti\-inflammatory medications within the last month.
- •9\.Occlusion therapy with lachrymal or punctum plugs within the last 2 months.
- •10\.Change in systemic treatment within the last 2 months.
结局指标
主要结局
未指定
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