Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00465621 |
Recruitment Status :
Completed
First Posted : April 25, 2007
Last Update Posted : July 29, 2008
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Sponsor:
Alcon Research
Information provided by:
Alcon Research
Tracking Information | ||||
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First Submitted Date ICMJE | April 23, 2007 | |||
First Posted Date ICMJE | April 25, 2007 | |||
Last Update Posted Date | July 29, 2008 | |||
Study Start Date ICMJE | March 2007 | |||
Actual Primary Completion Date | July 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Mean IP Change from Baseline | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension | |||
Official Title ICMJE | Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension | |||
Brief Summary | The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in patients with open-angle glaucoma or ocular hypertension | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Xalatan | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
150 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | July 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - VA worse than 0.60 |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00465621 | |||
Other Study ID Numbers ICMJE | C-06-10 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Alcon Research | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Alcon Research | |||
Verification Date | July 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |