Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy
NCT ID: NCT00966576
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
47 participants
INTERVENTIONAL
2009-07-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brinzolamide/Timolol Maleate Fixed Combination
Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)
1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks
Interventions
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Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)
1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 21 years of age or older.
* Able to follow instructions and willing to attend required study visits.
* Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
* Intra-ocular pressure (IOP) considered to be safe in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
* Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
Exclusion Criteria
* Presence of corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
* Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
* Women of childbearing potential not using reliable means of birth control.
* Women who are pregnant or lactating.
* Participation in any other investigational study within 30 days prior to Visit 1.
* Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
* Severe allergic rhinitis
* History of ocular herpes simplex.
21 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Mainz, , Germany
Countries
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References
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Lorenz K, Rosbach K, Matt A, Pfeiffer N. Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension. Clin Ophthalmol. 2011;5:1745-50. doi: 10.2147/OPTH.S25987. Epub 2011 Dec 9.
Other Identifiers
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SMA-08-22a
Identifier Type: -
Identifier Source: org_study_id