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Evaluation of MAF-1217 in Patients With DED

2019年7月12日 更新者：VISUfarma SpA

Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED

This is a pre-market, multicentre, double-blind, randomized, crossover, non-inferiority study comparing the efficacy of MAF-1217 and Cationorm® in adult patients with evaporative DED.

The study population will be divided in 4 different subgroups, according to the different types of evaporative DED:

  1. Group A: high evaporative levels
  2. Group B: females in menopause, whether using hormonal integration or not
  3. Group C: presence of active obstructive Meibomian gland disease
  4. Group D: glaucomatous patients

研究概览

地位

完全的

条件

干预/治疗

详细说明

Patients will be enrolled after having signed the informed consent form prior any other study procedure and after inclusion/exclusion criteria check.

Each patient will be planned to perform 6 study visits and at each visit all necessary study procedures will be performed according to the clinical investigation plan requirements (see flow-chart).

The study visits will be performed at: screening, baseline, week 2, week 6, week 8, week 12.

Patients will be enrolled at screening visit and at baseline, after the wash-out period of 1 week, then will be randomized to receive MAF-1217 or Cationorm® for the following 6 weeks.

After this time lapse, patients will be switched to the opposite therapy for 6 additional weeks.

The entire study population will be asked for a TID posology, and will be divided in 4 different subgroups, according to the different types of evaporative DED.

Certain test will be performed only in some patients:

Osmolimetry and tear sampling in 20 patients(10/site) chosen random from groups B, C and D; Ferning test only in group D; tear film collection and cytokine expression only in 20 patients form site nr. 2.

Patients will be allowed to carry on any systemic or local medications, apart lubricating eyedrops, which have to be stopped the day before baseline visit.

研究类型

介入性

注册 (实际的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
      • Milan、意大利、20121
        • Ospedale San Paolo, ASST Santi Paolo e Carlo
      • Milan、意大利、20157
        • ASST Fatebenefratelli Sacco P.O.L. Sacco

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. At least 18 years old (adult patients), male and female
  2. Schirmer I test > 10 mm at 5'
  3. (Group A): high evaporative levels
  4. (Group B): females in menopause, both using hormonal integration or not

  5. (Group C): presence of active obstructive Meibomian gland disease, defined as at least one of the following:

    • Meibomian orifice plugging
    • eyelid margin foaminess
    • changes in orifice position with respect to the mucocutaneous junction
    • abnormal Meibomian gland secretions (opaque and viscous-like form that is difficult to express)
  6. (Group D): glaucomatous patients receiving one or more BAK preserved treatments for at least 2 years, showing an abnormal Ferning test (Types 3 or 4 according to Rolando)
  7. all: wishing to participate in the study and able to sign the ICF

Inclusion criteria to be checked at baseline:

  1. BUT < 7"
  2. Mild to severe DED according to OSDI chart

Exclusion Criteria:

  1. Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
  2. Coexisting corneal diseases
  3. Autoimmune diseases
  4. Past or active cicatricial conjunctivitis
  5. Past ocular surface burns
  6. Keratinization of the eyelid margin
  7. Sjogren syndrome
  8. History of corneal trauma
  9. Pregnant and lactating women
  10. Younger than 18 years old patients
  11. Use of contact lenses
  12. inability to self administer study medications
  13. (GROUPS B, D) Presence of active obstructive Meibomian gland disease
  14. (GROUP C) Presence of cicatricial Meibomian gland disease
  15. known allergic sensitivity to any of the devices ingredients or any other known allergy
  16. participation in a clinical trial during the 3 months prior to the beginning of the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：MAF1217/Cationorm
设备：MAF1217
The study population will have to self-administer the study treatment in a TID posology.
其他：Cationorm
The study population will have to self-administer the study treatment in a TID posology.
实验性的：Cationorm/MAF1217
设备：MAF1217
The study population will have to self-administer the study treatment in a TID posology.
其他：Cationorm
The study population will have to self-administer the study treatment in a TID posology.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Break-up time (BUT) differences
大体时间：measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Changes in break-up time (BUT) versus baseline
measured at week 2, 6, 8 and 12 weeks treatment versus baseline

次要结果测量

结果测量
措施说明
大体时间
ocular surface staining (corneal and conjunctival)
大体时间：measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Cross-over analysis for the differences versus baseline between the two groups on changes in ocular surface staining (corneal and conjunctival)
measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Schirmer I test (ST) (without anesthesia)
大体时间：measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Cross-over analysis for the differences versus baseline between the two groups on changes in Schirmer I test (ST) (without anesthesia)
measured at week 2, 6, 8 and 12 weeks treatment versus baseline
number of blinking per minute
大体时间：measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Cross-over analysis for the differences versus baseline between the two groups on changes in number of blinking per minute
measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Ferning test (Group D)
大体时间：measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Cross-over analysis for the differences versus baseline between the two groups on changes in Ferning test (Group D)
measured at week 2, 6, 8 and 12 weeks treatment versus baseline
osmolarity
大体时间：measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Cross-over analysis for the differences versus baseline between the two groups on changes in osmolarity
measured at week 2, 6, 8 and 12 weeks treatment versus baseline
patient satisfaction (10 points VAS scale)
大体时间：measured at week 2, 6, 8 and 12 weeks treatment versus baseline

Cross-over analysis for the differences versus baseline between the two groups on changes in patient satisfaction (10 points VAS scale).

(VAS: scale where patient has to specify level of satisfaction by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no satisfaction while 10 represents the highest level).
measured at week 2, 6, 8 and 12 weeks treatment versus baseline
OSDI
大体时间：measured at week 2, 6, 8 and 12 weeks treatment
Changes in questionnaire scores (OSDI - Ocular Surface Disease Index). The overall Ocular Surface Disease score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.
measured at week 2, 6, 8 and 12 weeks treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

VISUfarma SpA

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年11月27日

初级完成 (实际的)

2019年6月19日

研究完成 (实际的)

2019年6月19日

研究注册日期

首次提交

2019年1月31日

首先提交符合 QC 标准的

2019年2月4日

首次发布 (实际的)

2019年2月7日

研究记录更新

最后更新发布 (实际的)

2019年7月15日

上次提交的符合 QC 标准的更新

2019年7月12日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VF-OS-001/2018

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Iran

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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