Efficacy of Changing to DUOTRAV® From Prior Therapy

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Timolol; Travoprost

Criteria

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.