Investigation of the efficacy and safety of preoperative IOP reduction with preservative-free COSOPT-S® (dorzolamide/timolol, MSD) eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma patients - COSOPT-S® Study

niversity Medical Center, Johannes Gutenberg-University Mainz0 个研究点开始时间: 2010年6月25日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•Male or female patients aged 18 years or older
•A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
•Previous treatment with antiglaucoma agents containing preservatives for at least one month
•Best corrected visual acuity of 20/800 or better in the study eye
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Secondary glaucoma except pseudoexfoliation glaucoma and pigmentary glaucoma
•Current ocular infection, i.e. conjunctivitis or keratitis
•Any abnormality preventing reliable applanation tonometry
•Intraocular surgery or laser treatment within the past three months
•History of surgery involving the conjunctiva
•History of cataract surgery with sklerocorneal approach
•Subject is allergic to sulfonamides
•Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
•Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
•Severe renal dysfunction (CrCl < 30 ml/min) or hyperchloraemic acidosis
•History of hypersensitivity to the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products

发起方

niversity Medical Center, Johannes Gutenberg-University Mainz