"Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."
试验速览
- 阶段
- 3 期
- 入组人数
- 22
- 主要终点
- time to regression of the ocular symptomatology
研究概览
简要总结
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.
详细描述
To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis.
- •Patients of both gender aged over 18 years.
- •Patients who are not pregnant or nursing.
- •Patients able (legally and mentally) to understand and sign informed consent had been signed.
排除标准
- •Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension.
- •Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk.
- •Patient with a single eye or vision in one eye.
研究组 & 干预措施
Ganciclovir
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
干预措施: Ganciclovir (Drug)
Ophthalmic gel (placebo)
ophthalmic gel (placebo)in the study eye
干预措施: Ophthalmic gel (placebo) (Drug)
结局指标
主要结局
time to regression of the ocular symptomatology
时间窗: 10 days
Time to regression of ocular symptomatology compared to the baseline, as determined by clinical evaluation (biomicroscopy) performed on V1, V2 and V3, based on scale of absent, mild, moderate and severe.
次要结局
- Development of sub-epithelial infiltrates(10 days)
- Degree of Bulbar conjunctival Injection(10 days)
- Involvement of the second eye(10 days)
- Patient Dairy - intensity of ocular pain(10 days)