Efficacy of Changing to DuoTrav From Prior Therapy



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:August 2011
End Date:August 2012
Contact:Alcon Call Center
Phone:1-888-451-3937

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Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)


The purpose of this study to assess the efficacy and tolerability of changing to DuoTrav®
from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in patients with open-angle
glaucoma or ocular hypertension.


Inclusion Criteria:

- Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma
in both eyes.

- IOP of 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.

- 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.
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