A Prospective Multicenter, Comparative, Randomized, Single-blind, Non-inferiority Study of Eyestil Protection® Unidose Versus Vismed® Unidose in Patients With Moderate to Severe Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- SIFI SpA
- 入组人数
- 21
- 试验地点
- 13
- 主要终点
- Primary endpoint/clinical performance by Oxford scale
研究概览
简要总结
This is a national, prospective, multicenter, comparative, randomized, single-blinded non-inferiority study performed in two parallel groups.
3 months (plus a run in period of 15 days prior inclusion) Patients with moderate to severe dry eye syndrome.
详细描述
Public hospitals and private practices specialized in ophthalmology Approximately 10 sites France Approximately 80 patients globally: 40 per arm with a 1:1 ratio including an expected dropout rate of 15%.
Dry eye has been defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms, in which the tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.
However, prevalence estimates for dry eye vary dramatically from 5% to 50% due to the various operational definitions of dry eye used and the characteristics of the population studied.
The available evidence suggests also that dry eye has a negative impact on overall quality of life. It causes pain and irritation and affects ocular and general health and well-being, the perception of visual function and visual performance. Reduced quality of life in everyday activities and leisure pursuits is reported by 60% of patients, while 38% of patients complain of reduced efficiency at work.
Therefore, the economic burden and impact of dry eye on vision and quality of life, work productivity, psychological and physical impact of pain are considerable. As a consequence, dry eye represents a public health burden. However, only a handful of therapies are available for dry eye patient and are used according to the disease severity.
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
- Single (Investigator)
盲法说明
Single Blind: investigator masked
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 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;
- •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)
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.
Clinical performance of the medical device under investigation: 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 time points of the Global Ocular Staining Score of the study eye (GOSS). 0-5 cornea; 0-5 temporal conjuctiva; 0-5 nasal conjunctiva. Max total score: 15
次要结局
- Secondary endpoint/safety(between Day 1 and Day 84 ±7)
- Secondary endpoint/patient reported outcome by DEQS questionnaire(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)
- Secondary endpoint/clinical performance by Schirmer test(between [Day 1 and Day 84 ±7])
- Secondary endpoint/patient reported outcome by OSDI score(between [Day 1 and Day 35 ±4] and [Day 1 and Day 84 ±7])
- Secondary endpoint/clinical performance by TBUT test(between Day 1 and Day 35 ±4 and Day 1 and Day 84 ±7)