Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
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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: NCT00575367 |
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Recruitment Status :
Completed
First Posted : December 18, 2007
Results First Posted : September 17, 2009
Last Update Posted : September 22, 2011
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by:
Merck Sharp & Dohme LLC
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care |
| Conditions |
Bacterial Infections Eye Infections |
| Interventions |
Drug: AzaSite (azithromycin ophthalmic solution) Drug: Vigamox (moxifloxacin hydrochloride ophthalmic solution) |
| Enrollment | 37 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | AzaSite | Vigamox |
|---|---|---|
 Arm/Group Description |
[Not Specified] | [Not Specified] |
| Period Title: Overall Study | ||
| Started | 19 | 18 |
| Completed | 19 | 18 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | AzaSite | Vigamox | Total | |
|---|---|---|---|---|
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Arm/Group Description |
[Not Specified] | [Not Specified] | Total of all reporting groups | |
| Overall Number of Baseline Participants | 18 | 17 | 35 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 18 participants | 17 participants | 35 participants | |
| 33.9 (12.59) | 38.1 (13.29) | 36.0 (12.92) | ||
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[1]
Measure Description: Baseline measures for two subjects were not included in this analysis due to missing data on too many data points. Although the total number of baseline participants was 37, the actual number included in the analysis was 35 subjects, 18 subjects in the Azasite group and 17 in the Vigamox group.
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 18 participants | 17 participants | 35 participants | |
| Female |
13 72.2%
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7 41.2%
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20 57.1%
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| Male |
5 27.8%
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10 58.8%
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15 42.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
PI cannot publish or discuss trial results until written communication is received from Inspire Pharmaceuticals, Inc.
Results Point of Contact
| Name/Title: | Karen Kuhn/ Director |
| Organization: | Inspire Pharmaceuticals, Inc. |
| Phone: | 919 941-9777 |
| EMail: | kkuhn@inspirepharm.com |
| Responsible Party: | Karen Kuhn, Inspire Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00575367 |
| Other Study ID Numbers: |
041-101 P08653 |
| First Submitted: | December 14, 2007 |
| First Posted: | December 18, 2007 |
| Results First Submitted: | August 10, 2009 |
| Results First Posted: | September 17, 2009 |
| Last Update Posted: | September 22, 2011 |