Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Alcon

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination

Study type

Interventional

Funder types

Industry

Identifiers

NCT01336569

SMA-09-26

Details and patient eligibility

About

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
On a stable medication regimen for IOP reduction one week prior to the screening visit;
Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
Sign informed consent;
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
Infection in either eye;
Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
Risk for visual field or visual acuity worsening, in the opinion of the investigator;
Women of childbearing potential;
Pregnant or lactating women;
Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
Participation in another clinical study within 30 days before the screening visit;
Other protocol-defined exclusion criteria may apply.