Divided Dose of TRAVATAN®

Alcon Research67 enrolled

Overview

The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Open-angle Glaucoma Ocular Hypertension

Interventions

Travoprost Ophthalmic Solution, 0.00013%DRUG

Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose

Travoprost Ophthalmic Solution, 0.00033%DRUG

Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose

Travoprost Ophthalmic Solution, 0.001%DRUG

Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria: 1. Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1; 2. Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1. * Must sign an informed consent form. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures. * Current or history of ocular inflammation or infection in either eye within the past 3 months. * Corneal thickness greater than 620 µm as determined by pachymetry in either eye. * Severe visual field loss. * Cup to disc ratio greater than 0.8 in either eye. * Intraocular surgery within the past 6 months in either eye. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

24-hour Area Under the Curve (AUC) in IOP Reduction

Time frame: Day 5

Data from ClinicalTrials.gov

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