ISRCTN48477221已完成不适用
Comparative clinical trial of the safety and efficacy of Krytantek Ofteno® formulated by Laboratorios Sophia S.A. de C.V. versus Combigan D® in the treatment of patients with primary open-angle glaucoma or ocular hypertension
aboratorios Sophia S.A. de C.V. (Mexico)0 个研究点目标入组 88 人开始时间: 2008年7月17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
- 88
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. Patients may be of both masculine or feminine genders and must be 18 years old or older
- •3. Patients with intraocular pressure between 21 - 30 mmHg
排除标准
- •1. Patients with one blind eye
- •2. Patients with visual acuity of 20/40 or worst in any of both eyes without a justifying cause
- •3. Patients with active stage history of any concomitant ocular disease besides the required one
- •4. Patients taking any medication, whether topically or by any route of administration, that decisively interferes in the study's results, until 48 hours previous to the day 1 of the trial or until a time period in which residual effects could be present
- •5. Sulfa allergy patients
- •6. Patients with history of hypersensibility or any medical situation that contraindicates or makes the using of risky for 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 lenses users
- •8. Fertile-age women 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 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 under 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 clinical trial
- •12. Patients who cannot comply with the medical appointments or with all the protocol requirements
- •13. Patients who refuse to participate in this clinical trial
- •14. Patients with optic disc excavation equal to 0.8 or more
- •15. Normal-tension glaucoma patients
研究者
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