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| Sponsor: | Allergan |
|---|---|
| Information provided by (Responsible Party): | Allergan |
| ClinicalTrials.gov Identifier: | NCT00538304 |
Purpose
A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Ocular Hypertension |
Drug: bimatoprost eye drops Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Enrollment: | 222 |
| Study Start Date: | November 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
bimatoprost eye drops
|
Drug: bimatoprost eye drops
1 drop in each eye daily for 1 month
|
|
Placebo Comparator: 2
placebo
|
Drug: placebo
1 drop in each eye daily for 1 month
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00538304 History of Changes |
| Other Study ID Numbers: | 192024-035 |
| Study First Received: | September 28, 2007 |
| Results First Received: | September 19, 2011 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Glaucoma Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Tetrahydrozoline Bimatoprost Nasal Decongestants Vasoconstrictor Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents |