Evaluation of the Performance of the Tear Substitute MAF-1217 in Patients With Evaporative DED
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Break-up time (BUT) differences
研究概览
简要总结
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:
- Group A: high evaporative levels
- Group B: females in menopause, whether using hormonal integration or not
- Group C: presence of active obstructive Meibomian gland disease
- Group D: glaucomatous patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old (adult patients), male and female
- •Schirmer I test > 10 mm at 5'
- •(Group A): high evaporative levels
- •(Group B): females in menopause, both using hormonal integration or not
- •(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)
- •(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)
- •all: wishing to participate in the study and able to sign the ICF
- •Inclusion criteria to be checked at baseline:
- •Mild to severe DED according to OSDI chart
排除标准
- •Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
- •Coexisting corneal diseases
- •Autoimmune diseases
- •Past or active cicatricial conjunctivitis
- •Past ocular surface burns
- •Keratinization of the eyelid margin
- •Sjogren syndrome
- •History of corneal trauma
- •Pregnant and lactating women
- •Younger than 18 years old patients
- •Use of contact lenses
- •inability to self administer study medications
- •(GROUPS B, D) Presence of active obstructive Meibomian gland disease
- •(GROUP C) Presence of cicatricial Meibomian gland disease
- •known allergic sensitivity to any of the devices ingredients or any other known allergy
- •participation in a clinical trial during the 3 months prior to the beginning of the study
结局指标
主要结局
Break-up time (BUT) differences
时间窗: measured at week 2, 6, 8 and 12 weeks treatment versus baseline
Changes in break-up time (BUT) versus baseline
次要结局
- ocular surface staining (corneal and conjunctival)(measured at week 2, 6, 8 and 12 weeks treatment versus baseline)
- Schirmer I test (ST) (without anesthesia)(measured at week 2, 6, 8 and 12 weeks treatment versus baseline)
- patient satisfaction (10 points VAS scale)(measured at week 2, 6, 8 and 12 weeks treatment versus baseline)
- number of blinking per minute(measured at week 2, 6, 8 and 12 weeks treatment versus baseline)
- Ferning test (Group D)(measured at week 2, 6, 8 and 12 weeks treatment versus baseline)
- osmolarity(measured at week 2, 6, 8 and 12 weeks treatment versus baseline)
- OSDI(measured at week 2, 6, 8 and 12 weeks treatment)