CTRI/2011/12/002313已完成3 期
Comparison of the efficacy and safety of Latanoprost 0.005% (Xalatan® Reference) and Latanoprost 0.005% (Sun Pharma Advanced Research Company Ltd) administered once daily in open angle glaucoma and ocular hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入选标准
- •Men and women aged 18 years and above.
- •Unmedicated IOP equal to or greater than 22 mmHg in one or both eyes
- •Visual acuity 6/60 or better
- •Willingness to participate and giving written informed consent
- •Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
排除标准
- •Pigmentary glaucoma
- •Intraocular conventional surgery or laser surgery within the past six months
- •Refractive surgery in study eye
- •Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy
- •Ocular trauma within the past 3 months
- •Progressive retinal or optic nerve disease apart from glaucoma
- •Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye
- •Contact lens wear within 15 minutes of instillation of study medication
- •Women of childbearing potential who have positive serum pregnancy test or are lactating or not using adequate contraception
- •Clinically significant systemic disease, which might interfere with the study
- •History of non-compliance to medical regimens or unwilling to comply with the study protocol
- •Participation in another clinical study within the last thirty (30) days
- •Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study
- •Refusal or inability to give written informed consent
研究者
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