A Prospective Multicenter, Comparative, Randomized, Double-blind, Non-inferiority Study of Eyestil® Plus Multidose Versus Vismed Multi® in Patients With Moderate to Severe Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 96
- 试验地点
- 12
- 主要终点
- Primary endpoint/clinical performance by Oxford scale
研究概览
简要总结
SIFI SpA had developed Eyestil Plus®. It is sterile eyedrops without preservatives with a physiological pH containing sodium hyaluronate. Its intended purpose is to moisturize, lubricate and protect the ocular surface and gives temporary relief to burning, irritation and dry eye-related discomfort, and other complaints induced, for example, by: prolonged use of either soft, semi rigid or rigid contact lenses; exposure to environmental factors (air conditioning, exposure to solar radiation, wind, smoke, pollution, severe climatic conditions, dust); ocular fatigue caused by studying, working, driving or prolonged exposure to electronic devices.
Eyestil Plus® is CE marked but not available yet in all European countries. Considering the European regulatory change on medical devices - from a Directive (Directive 1993/42/EEC) to a Regulation (MDR 2017/745) that now requires clinical evidence of device performance and safety; SIFI Spa decided to implement the present clinical comparative performance study. The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
详细描述
The aim of the study is to demonstrate the non-inferiority of Eyestil Plus® compared to Vismed Multi® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis. Secondly, the study is aimed at evaluating the safety profile of the product and the patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
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
- •Adult patients, male or female, of at least 18 years of age at the screening visit
- •Patients understanding the study, willing to follow the instructions and providing their written Informed Consent Form to participate
- •Patients with moderate up severe dry eye with keratoconjunctivitis sicca diagnosed at least 4 weeks before the screening visit
- •Patients using artificial tears at least once a day for at least 4 weeks months before the screening visit*
- •Patients with corneal/conjunctival lesions consistent with a diagnosis of keratoconjunctivitis measured by tests of staining: i.e. the overall score of the corneal staining test must be ≥ 3 and ≤ 9 on the 15-point Oxford scale
- •And at least one of the following element:
- •Tear volume decreased: must be either present a Schirmer test ≥ 3 mm and ≤ 9 mm / 5 minutes or the sum of 3 consecutive measurements of the tear film break-up time (TBUT) ≤ 30s for at least one eye An OSDI score ≥18
- •Covered by healthcare insurance.
排除标准
- •Patients with medical history of herpetic keratitis, peripheral ulcerative keratitis, sclerites, diabetic retinopathy
- •Any systemic disease that is not well controlled for at least 2 months (e.g. lupus, rheumatoid arthritis, thyroiditis...) according to clinical judgment
- •Patients using any topical therapies such as non-steroidal anti-inflammatory drugs, cortisone, cyclosporine, vasoconstrictor
- •Patients with at least one of the following concomitant ocular inflammatory disease: Stevens Johnson Disease, Atopic Keratoconjunctivitis; Scarlet Eye Pemphigoid
- •Patients with anomalies of the eyelid, sucking, infectious conjunctivitis, pterygia, and/or a glaucoma treated with eyedrops
- •Presence of graft versus host disease (GVHD)
- •Patients who have undergone surgery in the eye, within three months before the study enrolment
- •Patients who have undergone corneal transplantation or refractive surgery or plan to undergo any eye surgery in the next four months
- •Patients with known or suspected eye allergy
- •Patients with a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study
- •Female pregnant, planning a pregnancy during the study period and nursing an infant
- •Patients who are participating or have participated in other clinical trial with investigational drug or device within 30 days prior to screening
- •Patients unable to be compliant with the study procedures and requirements, according to the opinion of the investigator
- •Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
研究组 & 干预措施
Eyestil Plus®
It's a clinical comparative performance study. Eyestil Plus® eyedrops multidose to be not inferior to Vismed multidose eye drops. Eyestil Plus is an ophthalmic aqueous formulation, multidose sterile preservative free, medical device, class IIB and CE marked. It contains 0.4% sodium hyaluronate. It is not available yet in the French Market.
The dosage per medical device will be 6 drops a day per dry eye during the three months study period,
干预措施: Eyestil Plus® (Device)
Vismed
Vismed Multi® is also a sterile multidose preservative free, medical device class IIb and CE marked. It contains 0.18% sodium hyaluronate.
The dosage per medical device will be 6 drops a day per dry eye during the three months study period.
The choice of Vismed Multi® as the comparator has been done since it is the current French standard of care treatment for patients with moderate to severe dry eyes.
结局指标
主要结局
Primary endpoint/clinical performance by Oxford scale
时间窗: between Day 1 and Day 35 ±4
the between-group comparison of the average variation of the global fluorescein corneal and lissamine green conjunctival staining using the Oxford scale (0 to 15). This refers to the average variation between both timepoints of the Global Ocular Staining Score of the study eye (GOSS) and the comparison between both treatment groups. 0-5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15
次要结局
- secondary endpoint/clinical performance by TBUT test(between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7)
- secondary endpoint/clinical performance by Oxford scale(between Day 1 and Day 84 ±7 days)
- secondary endpoint/clinical performance by Schirmer Test(test between Day 1 and Day 84 ±7)
- secondary endpoint/patient symptoms by Ocular Symptoms Disease Index (OSDI) score(Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7)
- secondary endpoint/patient symptoms by Dry Eye-Related Quality -of-Life(DEQS) questionnaire(Day 1 and Day 35 ±4 and [Day 1 and Day 84 ±7)
- secondary endpoint/safety(Day 1 and Day 84 ±7)
- secondary endpoint/Investigator overall treatment satisfaction using by a four-point scale(Day 35±4 and Day 84 ±7)