Comparison of the Clinical Efficacy and Tolerability of Latanoprost RDR 0.005% Eye Drops Test Formulation of RDR Pharma GmbH, Germany, for the Treatment of Ocular Hypertension and Primary Open Angle Glaucoma, with Xalatan® 0.005% Eye Drops. A multicenter, randomized, investigator-blind, clinical trial with parallel groups

RDR Pharma GmbH0 个研究点目标入组 260 人开始时间: 2009年1月7日最近更新: 2012年3月19日

适应症

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•written informed consent
•male and female patients with unilateral or bilateral OH (defined by an IOP > 22 mmHg at several measurements) or POAG at an early stage (defined by a mean defect between 0 and -12 db in a visual field performed with an automated perimeter within the 3 months before the study)
•age = 18 years
•with at least in one eye, IOP above or equal 22 mmHg at 8 am and below or equal 30 mmHg at 8 am, 12 noon and 4 pm under one of the following conditions:
•-patients with untreated OHT or
•-patients completing the 4-week washout period of an initial monotherapy with a prostaglandin or beta-blocker
•patients whose initial therapy requires a washout may, upon decision of the investigator, be treated within this period by dorzolamide or a miotic, which will be stopped 1 week or 3 days, respectively, before study treatment initiation
•best corrected visual acuity = 20/100 (Snellen) or 2/10 (Monoyer)
•female subjects must be using a medically accepted form of birth control and must have a negative urine pregnancy test at screening
•able to provide informed consent after risks and benefits of the study have been explained
•ability to communicate effectively with study personnel.
•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

•in both eyes, IOP< 22 mmHg at 8 a.m. without any treatment or after a washout period
•in the eye(s) to be treated, IOP > 30 mmHg at 8 a.m. or 12 noon or 4 p.m.
•known sensitivity to latanoprost or any component of the drug products
•use of contact lenses;
•previous or active corneal disease;
•monophthalmia;
•history of macular oedema;
•any intraocular infection or inflammation within the previous 3 months;
•ocular surgery or severe trauma within the previous 3 months;
•intraocular laser therapy within the last 3 months;
•angle closure, congenital and secondary glaucoma (including pigmentary glaucoma);
•ocular corticosteroids;
•need of any other topical or systemic treatment of OH or POAG;
•pregnancy or breastfeeding;
•severe dysfunction of the liver or the kidneys;
•active wasting disease including cancer;
•angina pectoris not controlled by medical or surgical treatment;
•severe asthma bronchiale (FEV1 < 70% of predicted value);
•haematological diseases such as aplastic anaemia, pancytopenia, or haemolytic icterus;
•current or anamnestic drug addiction or extensive alcohol use;
•participation in another clinical study within 4 weeks prior to enrolment;
•history of non-compliance;
•any condition that compromises the ability to understand or comply with
•study requirements;
•committed to an institution by virtue of an order issued either by the judicial or the
•administrative authorities.

发起方

RDR Pharma GmbH