ISRCTN26988657已完成不适用
Comparative trial of a 0.5% timolol-2% dorzolamide-0.2% brimonidine solution in fixed combination versus Cosopt® in open angle glaucoma or ocular hypertension
aboratorios Sophia S.A de C.V. (Mexico)0 个研究点目标入组 100 人开始时间: 2008年12月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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. Patients must have a clinical diagnosis of mild to moderate primary open-angle glaucoma (POAG) with or without pseudoexfoliation and pigmentary dispersion or ocular hypertension
- •2. Both males and females, aged 18 years or older
- •3. Patients with intraocular pressure between 21 and 30 mmHg
排除标准
- •1. Patients with one blind eye
- •2. Patients with visual acuity of 20/40 or worse in either of the two eyes without a justifying cause
- •3. Patients with a history of any concomitant, active-stage ocular disease except the diseases specified in the inclusion criteria
- •4. Patients taking any medication, regardless of the route of administration, that decisively interferes with the study results, until 48 hours prior to start of the trial or until a time period in which residual effects could be present
- •5. Sulfa allergy
- •6. Patients with history of hypersensibility or any medical situation that contraindicates or makes risky the use of any of the study articles or their compounds under any route of administration as well as any drug or formulation derived from them or related to them
- •7. Contact lens users
- •8. Women of childbearing potential who are not using an adequate contraceptive method, as well as pregnant or breast-feeding women
- •9. Patients with history of cataract surgery with or without intraocular lens (IOL) implant (pseudoaphakia or aphakia) three months or less prior to Day 1 of the trial
- •10. Patients enrolled in any medical trial out of the Laboratorios Sophia S.A. de C.V. sponsorship within the last 90 days prior to this trial
- •11. Legally disqualified or mentally disabled patients who cannot sign the informed consent to participate in this trial
- •12. Patients who cannot comply with the medical appointments or with all the protocol requirements
- •13. Patients who disagree to participate in this trial
- •14. Patients with optic disc excavation greater than or equal to 0.8
- •15. Normal-tension glaucoma patients
研究者
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