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This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bimatoprost 0.01% ophthalmic solution |
|
| 2 | Experimental | Bimatoprost 0.015% formulation 1 ophthalmic solution |
|
| 3 | Experimental | Bimatoprost 0.015% formulation 2 ophthalmic solution |
|
| 4 | Experimental | Bimatoprost 0.02% ophthalmic solution |
|
| 5 | Active Comparator | Bimatoprost 0.03% ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.01% ophthalmic solution | Drug | One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort | Days 1-4 | |
| Patient Satisfaction | Day 5 | |
| Treatment Preference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wenatchee | Washington | United States |
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| Bimatoprost 0.015% formulation 1 ophthalmic solution | Drug | One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop |
|
| Bimatoprost 0.015% formulation 2 ophthalmic solution | Drug | One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop |
|
| Bimatoprost 0.02% ophthalmic solution | Drug | One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop |
|
| Bimatoprost 0.03% ophthalmic solution | Drug | Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs |
|
|
| Day 5 |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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