Randomized, Double-Masked, Active Controlled, Crossover Phase III

INTERVENTION: Product Name: Travoprost 0.004% eye drops solution Product Code: Travoprost 0.004% eye drops solution Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Travoprost CAS Number: 157283‐68‐6 Other descriptive name: TRAVOPROST Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 40‐ Trade Name: Travatan® 40 Mikrogramm/ml Augentropfen Product Name: Travatan® 40 Mikrogramm/ml Augentropfen Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Travoprost CAS Number: 157283‐68‐6 Other descriptive name: TRAVOPROST Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 40‐ CONDITION: Open Angle Glaucoma or Ocular Hypertension ; MedDRA version: 13.1 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 ‐ Eye disorders PRIMARY OUTCOME: Main Objective: To assess the equivalence of the topically administered Travoprost 0.004 % eye drops, solution (test formulation) compared to Travatan® 40 µg/ml Augentropfen (reference formulation) in lowering intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension. Primary end point(s): The primary efficacy parameter will be the difference in IOP of the study eye from visit 1 (baseline) to day 42 ± 5 in each period:; dIOP =IOP baseline – IOP travoprost Secondary Objective: To assess the safety and tolerability of repeated topical administration of; Travoprost 0.004 % eye drops, solution in subjects with open angle glaucoma or; ocular hypertension. INCLUSION CRITERIA: Main INCLUSION CRITERIA: ‐ Informed consent signed by the subject ‐ Male and 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 ‐ IOP controllable on one drug treatment in the study eye in a way that assures clinical stability of vision and the optic nerve throughout the study ‐ Baseline IOP > 20 mmHg in the untreated study eye (in eyes not included in the study IOP must be controlled by either no pharmacological treatment, or by the study medicine or by initial therapy) at visit 2 ‐ Best corrected visual acuity of 20/200 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