EUCTR2009-010971-26-DE进行中（未招募）不适用
A Phase II trial comparing Brivudin 0.1% ophthalmic solution with Aciclovir 3 % ophthalmic ointment in the treatment of patients with herpetic dendritic keratitis
Menarini Ricerche S.p.A.0 个研究点目标入组 50 人开始时间: 2009年8月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Male or female Caucasian patients between 18 and 80 years of age. A female of childbearing potential may be enrolled providing she:
- •has a negative pregnancy test at baseline and
- •is routinely using a highly effective method of birth control resulting in a low failure rate;
- •-Patients with clinically verified diagnosis of unilateral herpetic dendritic keratitis, either as primary episode or recurrence, showing all of the following:
- •characteristic corneal lesions due to herpetic dendritic keratitis evidenced by fluorescein staining in slit lamp examination;
- •onset of signs and symptoms less than 7 days preceding diagnosis/randomisation;
- •-Able to give written informed consent before any study related procedure;
- •-Able to attend all the visits scheduled in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with any stromal infiltrations/lesions, anterior chamber involvement, or any affection of deeper structures of the eye (e.g. keratouveitis);
- •-Patients suffering from any disease limiting eye lid closure function such as eye lid deformities, exophthalmus, facial palsy;
- •-Patients with bilateral herpetic keratitis;
- •-Patients with any corneal or conjunctival bacterial superinfection of the affected eye;
- •-Patients with a visual acuity of the contralateral, unaffected eye of 6/60 (20/200) or less;
- •-Patients with an intraocular pressure > 30 mmHg in the affected eye ;
- •-Patients having received local antiherpetic treatment (local antivirals and/or local steroids) within 8 weeks prior to study entry;
- •-Patients who received systemic antiviral therapy within 1 month prior to study entry;
- •-Patients under immunosuppressive therapy, including continuous treatment with systemic steroids;
- •-Patients who underwent tissue transplantation (e.g. amniotic membrane transplantation or keratoplasty [PKP]);
- •-Patients with a history of recurrences of epithelial herpetic keratitis known to be caused by HSV-2;
- •-Patients with a history of hypersensitivity to aciclovir;
- •-Patients with a history of hypersensitivity to brivudin;
- •-Patients with known HIV infection;
- •-Patients treated with any 5-fluoropyrimidines (e.g. 5-FU, tegafur, capecitabin, or flucytosin) within 1 month prior to study entry;
- •-Patients with any serious intercurrent illness which, in the opinion of the Investigator, is incompatible with the protocol (e.g. systemic infections, sepsis, severe atopic diseases, malignant diseases);
- •-Pregnant or breast feeding women;
- •-Patients who received any other investigational agent within 30 days prior to study entry;
- •-Patients not suitable for adequate follow up.
研究者
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