Efficacy of Changing to DUOTRAV® From Prior Therapy

Alcon

Status and phase

Completed

Phase 4

Conditions

Open-Angle Glaucoma

Pigment Dispersion Glaucoma

Ocular Hypertension

Treatments

Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01327599

2011-000161-13 (EudraCT Number)

RDG-10-272

Details and patient eligibility

About

The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
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.
Able to follow instructions and willing and able to attend all study visits.
Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
Sign informed consent.
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.
A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
Participation in any other investigational study within 30 days prior to the Screening Visit.
Other protocol-defined exclusion criteria may apply.