A multi-center, double-masked study of the safety and efficacy of Travoprost APS compared to TRAVATAN in patients with open-angle glaucoma or ocular hypertension. - Efficacy study of Travoprost APS versus TRAVATAN

INTERVENTION: Product Name: Travoprost APS (40 micrograms/ml) Product Code: FID 113887 Pharmaceutical Form: Eye drops, solution INN or Proposed INN: TRAVOPROST CAS Number: 157283‐68‐6 Current Sponsor code: AL‐6221 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 40‐ Trade Name: TRAVATAN Pharmaceutical Form: Eye drops, solution CONDITION: Open‐angle glaucoma or ocular hypertension ; MedDRA version: 9.1 Level: LLT Classification code 10030348 Term: Open angle glaucoma ; MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension PRIMARY OUTCOME: Main Objective: To compare the efficacy and safety of Travoprost APS to TRAVATAN Solution, both dosed once‐daily in the evening, in patients with open‐angle glaucoma or ocular hypertension Primary end point(s): Primary efficacy: Mean IOP; Safety: Adverse Events Secondary Objective: INCLUSION CRITERIA: 1. Patients, of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Diagnosis of ocular hypertension in treatment‐naïve patients should be documented as elevated IOP (i.e., =21 mmHg) at multiple points within the past year. 2. Patients not currently on any IOP‐lowering medication or currently on a stable treatment (i.e., at least 30 days) with an IOP‐lowering monotherapy (not a fixed combination product) medication. 3.Patients must meet the following IOP entry criteria in at least one eye at Eligibility Visits 1 & 2: •Mean IOP = 24 mmHg at the 09:00 time point, and •Mean IOP = 21 mmHg at the 11:00 and 16:00 time points. •The mean IOP in either eye at Screening or Eligibility must not be greater than 36 mmHg at any time point. The mean IOP is the average of IOP measurements in the same eye. The same eye(s) must qual