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

• Conditions: Ocular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and -12 db in a visual field); MedDRA version: 9.1Level: LLTClassification code 10030043Term: Ocular hypertension; MedDRA version: 9.1Level: LLTClassification code 10036719Term: Primary open angle glaucoma

• Registration Number: EUCTR2008-002122-10-DE
• Lead Sponsor: RDR Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine that the effectiveness and tolerability of Latanoprost RDR 0.005% Eye Drops Test Formulation is not inferior to Xalatan 0.005% Eye Drops.;Secondary Objective: Not Applicable;Primary end point(s): The primary end point for the evaluation of the efficacy shall be the mean change of 8 a.m. IOP measured on the study eye from the baseline value to the end of the trial.