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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01111890 |
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Date of registration:
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26/04/2010 |
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Primary sponsor: |
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Public title:
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Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension
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Scientific title:
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Date of first enrolment:
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April 2010 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01111890 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Must be at least 18 years of age.
2. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment
dispersion glaucoma in at least one eye (study eye).
3. Must have 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 study period.
4. Must be willing to discontinue the use of all other ocular hypotensive agents prior
to receiving the assigned study drug at Visit 1, throughout the study period.
5. Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the
study eye).
6. For the eyes not included in the study, the intraocular pressure should be able to be
controlled on no pharmacologic therapy or on the study medicine alone.
Exclusion Criteria:
1. Known medical history of allergy, hypersensitivity or poor tolerance to any
components of the preparations to be used in this study that is deemed clinically
significant in the opinion of the Principal Investigator.
2. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
3. Any abnormality preventing reliable applanation tonometry in study eye(s).
4. Risk of visual field or visual acuity worsening due to participation in the study, in
the investigator's best judgment.
5. Progressive retinal or optic nerve disease from any cause.
6. Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers,
alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium
channel blockers), which have not been on a stable course for 7 days prior to Day 1
Visit or an anticipated change in the dosage during the course of the study.
7. 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.
8. Participation in any other investigational study within 30 days prior to Visit 1.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glaucoma
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Intraocular Hypertension
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Intervention(s)
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Drug: Azarga (brinzolamide 1% / timolol 0.5%)
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Drug: Cosopt (dorzolamide 2% / timolol 0.5%)
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Primary Outcome(s)
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Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Percentage of subjects with IOP = 18 millimeters mercury (mmHg)
[Time Frame: 12 weeks]
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Secondary ID(s)
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SMA-09-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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