NCT00134992已完成4 期
Single-Center, Randomized, Double Masked, Two-Period Cross-Over, Three Days Per Period, Phase IV Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tolerability of the trial drug by evaluating the overall sum-score of the slit lamp examination built by adding up the scores for conjunctival hyperemia, conjunctival edema, palpebral hyperemia, lid edema and corneal edema
研究概览
简要总结
The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye drops by testing the hypothesis that the ocular safety and tolerability of prednisolone acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected and have been treated by using a crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects of either gender, 18 years or older, who were able to give an informed consent
- •A score for ocular discomfort of 0-20 mm on the visual analogue scale (VAS) prior to treatment
排除标准
- •Known hypersensitivity to any of the constituents of the medications
- •Known corticosteroid responder (elevation of intraocular pressure [IOP])
- •Known allergic disposition (e.g. hay fever)
- •Need of ocular antiallergic treatment
- •Wearing of contact lenses
- •Any kind of current eye disease (e.g. dry eye)
- •Any kind of concomitant ocular treatment
- •Any injury or infection in either eye during the last 3 months prior to the first application
- •Any medication taken within the last 28 days prior to the first application, except hormonal contraceptives
- •Concomitant or previous treatment with antihistamines within a week prior to enrolment
- •Pregnant or breast feeding women
- •Participation in another clinical study within 4 weeks prior to enrolment
- •Hematological diseases such as aplastic anemia, panmyelopathy, or hemolytic icterus; with severe dysfunction of the liver.
- •Any medical or laboratory condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial per protocol
- •Subjects with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exist, are excluded, with the exception of localized basal cell carcinoma of the skin
结局指标
主要结局
Tolerability of the trial drug by evaluating the overall sum-score of the slit lamp examination built by adding up the scores for conjunctival hyperemia, conjunctival edema, palpebral hyperemia, lid edema and corneal edema
次要结局
- Tolerability of the trial drug
- and the frequency, severity and relationship to study medication of all adverse events occurring during the course of the study.
研究者
研究点 (1)
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