Evaluation of Wharton's Jelly Extract Eye Drops, Treated by the AMTRIX Process, in the Treatment of Chronic Keratitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect
研究概览
简要总结
The purpose of this open, non-comparative, multicenter trial is to assess the impact of eye drops made of Wharton's jelly extract in the treatment of chronic keratitis that failed available therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between 18 and 70 years old.
- •Persistent corneal ulceration.
- •Resistance to medical treatment for more than one month or recurrence after medical treatment.
- •Patient who underwent a wash-out period of 15 days with no use of eye drops with preservative.
- •Patient with dry eye treatments that can be kept: tear substitutes, cyclosporine.
- •Informed and consenting patient.
- •Patient affiliated to a social security system or beneficiary of such a system.
排除标准
- •Patient with active infectious or traumatic keratitis such as burns.
- •Patient with herpetic keratitis.
- •Patient currently wearing contact lens, including scleral lenses concomitant with the treatment.
- •Patient currently treated with NSAIDs in eye drops or any eye drops containing preservatives.
- •Patient treated with antibiotic, anti-viral or anti-parasitic eye drops; with autologous or allogeneic serum; with platelet derivatives; with eye drops claiming healing properties; with eye drops containing growth factors, hyaluronic acid or trehalose.
- •Patient with hypersensitivity to fluorescein.
- •Patient with identified causes for keratitis for which discontinuation of medical treatment is beneficial.
- •Monophthalmic patients.
- •Persons deprived of liberty by a judicial or administrative decision.
- •Adults who are subject to a legal protection measure or who are unable to express their consent.
- •Pregnant woman.
结局指标
主要结局
Absence of aggravated inflammatory signs, worsening of visual acuity or other side effect
时间窗: Through study completion - average of 40 days
Inflammatory signs evaluated using a composite score on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye
次要结局
- Improvement of visual acuity(7 days, 15 days, 40 days)
- Re-epithelialization of the cornea(7 days, 15 days, 40 days)
- Improvement of dry eyes signs and symptoms(7 days, 15 days, 40 days)