ISRCTN31673586已完成不适用
Randomised, parallel-group, multicentre study to evaluate the after-use sensation and safety of carteolol LA 2% versus timolol LA 0.5% in simple intra-ocular hypertension and glaucoma
Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)0 个研究点目标入组 194 人开始时间: 2010年3月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult patients, men or women
- •2. Suffering from unilateral or bilateral ocular hypertension or POAG
- •3. Intraocular Pressure (IOP) controlled with beta-blocker monotherapy (IOP < 21mmHg and
- •visual field stable)
- •4. Written informed consent
排除标准
- •1. Age < 18 years
- •2. IOP not controlled with beta-blocker monotherapy
- •3. Angle closure, congenital and secondary glaucoma
- •4. Any pathology contraindicating an IOP measurement
- •5. Any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months
- •6. Previous intolerance to carteolol or timolol, or to any other ingredients of
- •the tested products
- •7. Beta-blocker contraindications
- •8. Ocular corticosteroids
- •9. Contact lens wearers
- •10. Severe systemic or ocular disease
- •11. Hypotension
- •12. Drug, alcohol abuse
- •13. Involvement in the last 30 days in any other investigational drug study
- •14. Expected change in treatment of concomitant disease
- •15. Patients with a history of recurrent ocular herpes and/or recurrent uveitis
- •16. Change in ocular treatment within the last month
- •17. Patients treated with other topical ocular treatment within the last month
- •18. Pregnant or lactating women
- •19. Women of child-bearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy
- •20. Patients for whom, in the physician's opinion, any of the protocol
- •procedures may pose a special risk not outweighed by the potential benefits of participating in the study
- •21. Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow up in the study period
- •22. Patients with neurotic, psychiatric disorders or suicidal tendencies
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