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Sponsored by: |
Allergan |
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Information provided by: | Allergan |
ClinicalTrials.gov Identifier: | NCT00538304 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
---|---|
1: Experimental |
Drug: bimatoprost eye drops
1 drop in each eye daily for 1 month
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2: Placebo Comparator |
Drug: placebo
1 drop in each eye daily for 1 month
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 192024-035 |
Study First Received: | September 28, 2007 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00538304 |
Health Authority: | United States: Food and Drug Administration |
Bimatoprost Glaucoma Eye Diseases Vascular Diseases |
Tetrahydrozoline Hypertension Ocular Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |