双面罩控制试验的H-1337作为治疗玻璃眼和眼睛高血压的治疗方法
Lee Shettle1, Jay Mulaney2, Robert D Williams3
1Shettle Eye Research, Largo, Florida, USA.
概括
这项2B期研究评估了H-1337用于治疗青光瘤和眼高血压,发现它在降低眼内压力 (IOP) 方面与蒂莫洛尔相当,尽管没有达到严格的非劣势边际.
科学领域:
- 眼科医生 眼科 眼科
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 玻璃眼和眼睛高血压是全球不可逆转失明的主要原因.
- 有效管理眼内压力 (IOP) 对于预防视神经损伤至关重要.
研究的目的:
- 评估H-1337.7的额外度和剂量频率.
- 为了比较H-1337的疗效和安全性与蒂摩洛尔马莱酸盐,一个积极的对照.
主要方法:
- 阶段2B,随机,双面罩,主控,剂量反应研究.
- 201名参与者患有开角玻璃眼或眼睛高血压.
- 在28天内用H-1337测量了24小时内心压力 (0.6%二日,1.0%二日,1.0%四日). 和提摩洛尔马莱酸0.5%两日一次.
主要成果:
- H-1337显示了与蒂莫洛尔可比的眼部低血压疗效.
- 平均IOP降低范围为H-1337组的4-7 mmHg和蒂莫洛尔的5-8 mmHg.
- 高血压是最常见的不良事件,H-1337的发生频率高于提摩洛尔.
结论:
- H-1337在降低内脏压力方面显示出与蒂莫洛尔相当的疗效.
- 非劣势差额未被严格遵守,可能是由于样本大小.
- 对于H-1337在青光眼治疗中的作用,可能需要进一步的研究.
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