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| Tracking Information | |||||
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| First Received Date ICMJE | September 28, 2007 | ||||
| Last Updated Date | September 10, 2008 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Conjunctival hyperemia [ Time Frame: Month 1 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Conjunctival hyperemia; IOP | ||||
| Change History | Complete list of historical versions of study NCT00538304 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
IOP [ Time Frame: Month 1 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension | ||||
| Official Title ICMJE | |||||
| Brief Summary | A one month study which will determine the safety and efficacy of bimatoprost eye drops in patients with glaucoma or ocular hypertension |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 222 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00538304 | ||||
| Responsible Party | Therapeutic Area Head, Allergan, Inc. | ||||
| Study ID Numbers ICMJE | 192024-035 | ||||
| Study Sponsor ICMJE | Allergan | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Allergan | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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