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Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azopt | Active Comparator | topical eye drop dosed 1 drop 3 times daily |
|
| Cosopt | Active Comparator | topical eye drop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azopt | Drug | topical eye drop dosed 1 drop 3 times daily |
| |
| Cosopt |
| Measure | Description | Time Frame |
|---|---|---|
| IOP reduction from baseline at the end of 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IOP reduction from baseline at the end of 4 and 8 weeks of treatment | 4 and 8 weeks |
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Inclusion Criteria:
Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.
If of child bearing potential
* Must use a reliable means of contraception for the duration of the study or surgically sterilized.
Must have a negative pregnancy test.
Must be non-lactating
IOP measurements ≥ 24 ≤ 36 mm Hg, in at least one eye, at 9.00 a.m and ≥ 21 ≤ 36 mm Hg in at least one eye (the same eye) at 11.00 am measurement
The IOP criteria to be met at both time points by the same eye
Visual Acuity of 6/24 or better in study eye (s)
Gonioscopy angle of ≥ 2 in the study eye (s)
Patients with a level of understanding and willingness to fully comply with all visits and study procedures scheduled by the study site as evidenced by written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Laboratories, India | Bangalore | 560016 | India |
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| Drug |
topical eye drop dosed 1 drop 2 times daily |
|
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| C479140 | dorzolamide-timolol combination |
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