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

INTERVENTION: Product Name: Latanoprost Pharmaceutical Form: Eye drops, solution INN or Proposed INN: LATANOPROST CAS Number: 130209824 Current Sponsor code: latanoprost Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1,5‐ Trade Name: Xalatan 0,005% Augentropfen Product Name: Xalatan Pharmaceutical Form: Eye drops, solution INN or Proposed INN: LATANOPROST CAS Number: 130209824 Current Sponsor code: Xalatan Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1,5‐ CONDITION: Ocular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and ‐12 db in a visual field) ; MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension ; MedDRA version: 9.1 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma PRIMARY OUTCOME: 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. 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. Secondary Objective: 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