Efficacy and Safety of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination BID vs. Brinzolamide 1% BID Plus Brimonidine 0.2% BID
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| City: |
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Fort Worth |
| State: |
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Texas |
| Zip Code: |
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76134 |
| Conditions: |
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Open-angle Glaucoma or Ocular Hypertension |
| Purpose: |
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A multi-center, double-masked, randomized parallel group efficacy and safety study of
brinzolamide 1% /brimonidine 0.2% fixed combination compared to brinzolamide 1% plus
brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Patients 18 years of age or older, of either gender, and any race/ethnicity,
diagnosed with open-angle glaucoma or ocular hypertension who in the opinion of the
Investigator are insufficiently controlled on monotherapy or are currently on
multiple IOP-lowering medications.
- Patients meeting qualifying IOP entry criteria.
- Able to understand and sign an informed consent form that has been approved by an
Institutional Review Board/Independent Ethics Committee.
Exclusion Criteria:
- Schaffer angle Grade < 2
- Cup/disc ratio greater than 0.80
- Severe central visual field loss
- Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent)
- Chronic, recurrent or severe inflammatory eye disease
- Clinically significant or progressive retinal disease
- Other ocular pathology
- Patients with recent use of high-dose (>1 gm daily) salicylate therapy
- Recent, current, or anticipated treatment with any medication that augments
adrenergic responses, or precludes use of an alpha-adrenergic agonist
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| NCT ID: |
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NCT01309204 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Fort Worth, Texas 76134 United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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