REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Epithelial corneal surface healing
研究概览
简要总结
The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.
详细描述
Extracellular matrix, composed of glycosaminoglycans (GAG) and matricial proteins, has a key role in tissular homeostasis.
The matrix therapy is a new class of medical substance, called RGTAs, ReGeneraTing Agents, consist of chemically engineered polymers adapted to interact with and protect against proteolytic degradation of cytokines.
OTR4120 (CACICOL20) is an heparan sulphate (HS) mimetic that can replace the degraded HS and protect and improve the bioavailability of cytokines. It aims to facilitate and potentiate the wound healing by restorating the natural microenvironment.
CACICOL20 was used in treating corneal dystrophies and chronic corneal ulcers. It significantly favored corneal healing. It was well tolerated with no side effects.
Bacterial keratitis is a serious ocular condition that may result in significant sight-threatening corneal sequelae. The common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensational impairment, chronic use of topical steroids, and systemic immunosuppression. Serious cases of keratitis are hospitalized to administrate an intensive hospital-made local antibiotic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •- Hospitalized patients for bacterial keratitis in Ophthalmology Department, Clermont-Ferrand university hospital .with a controlled local infection after 48 hours local antibiotics.
- •with a corneal ulcer diameter > 2 millimeters
排除标准
- •- Ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated, requiring a surgical intervention < 15 days.
- •Clinical suspicion and/or microbiological evidence of fungal or parasitic infection
- •Non controlled infection in spite of 48 hours intensive local antibiotics
- •Silver or copper salts treatment
- •Ocular surgery within the last 1 month
- •Unable to follow up medical examinations for geographical, social, physical or psychological reasons
- •Patient already included in another clinical trial
- •Pregnant patients or breastfeeding
- •Person under a legal protection measure, under guardianship
- •Not cover by social insurance.
结局指标
主要结局
Epithelial corneal surface healing
时间窗: at day 1
each day, from date of randomization until the date of the complete corneal healing assessed to fifteen days, up to 2 months
次要结局
- Healing time of total corneal epithelial wound(at day 1)
- Visual acuity(at day 1 and day 12)
- Ulcer deep(every day between day 0 to day 12)
- Healing keratitis rate(at day 12)