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 sites260 target enrollmentJanuary 7, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ocular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and -12 db in a visual field)
Sponsor: RDR Pharma GmbH
Enrollment: 260
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

January 7, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

RDR Pharma GmbH

•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

•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;