Phase 4 Study Comparing IOP Lowering in OAG or OH in Caucasian or Japanese Subjects C-02-32
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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: NCT00047606 |
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Recruitment Status :
Terminated
(Management Decision)
First Posted : October 11, 2002
Last Update Posted : August 17, 2012
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Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | October 8, 2002 | ||
| First Posted Date ICMJE | October 11, 2002 | ||
| Last Update Posted Date | August 17, 2012 | ||
| Study Start Date ICMJE | August 2002 | ||
| Actual Primary Completion Date | November 2003 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE | Not Provided | ||
| Original Primary Outcome Measures ICMJE | Not Provided | ||
| 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 | Phase 4 Study Comparing IOP Lowering in OAG or OH in Caucasian or Japanese Subjects C-02-32 | ||
| Official Title ICMJE | Phase 4 Study to Compare Two Different IOP Lowering Medications for the Treatment of Open Angle Glaucoma or Ocular Hypertension in Caucasian and Japanese Subjects C-02-32. | ||
| Brief Summary | The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after six weeks of treatment in Caucasian and Japanese subjects. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: IOP Lowering Medications | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
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* 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 | Terminated | ||
| Actual Enrollment ICMJE |
84 | ||
| Original Enrollment ICMJE | Not Provided | ||
| Actual Study Completion Date ICMJE | November 2003 | ||
| Actual Primary Completion Date | November 2003 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Adults of Caucasian and Japanese Ethnicity | ||
| 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 | Not Provided | ||
| Removed Location Countries | United States | ||
| Administrative Information | |||
| NCT Number ICMJE | NCT00047606 | ||
| Other Study ID Numbers ICMJE | C-02-32 C-02-32 |
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| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Alcon Research | ||
| Study Sponsor ICMJE | Alcon Research | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Alcon Research | ||
| Verification Date | August 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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