Safety and Efficacy of Changing to DuoTrav From Prior Therapy

Alcon

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230736

RDG-10-243

Details and patient eligibility

About

The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
Women who are pregnant or lactating.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
Corneal dystrophies in either eye.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
History of severe allergic rhinitis.
Other protocol-defined exclusion criteria may apply.