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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Condition: |
Eyelashes |
| Interventions: |
Drug: Bimatoprost 0.03% sterile solution Drug: vehicle sterile solution |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Bimatoprost 0.03% Solution | No text entered. |
| Vehicle Solution | No text entered. |
| Bimatoprost 0.03% Solution | Vehicle Solution | |
|---|---|---|
| STARTED | 137 | 141 |
| COMPLETED | 131 | 126 |
| NOT COMPLETED | 6 | 15 |
| Adverse Event | 4 | 4 |
| Lost to Follow-up | 0 | 3 |
| Withdrawal by Subject | 1 | 0 |
| Protocol Violation | 0 | 2 |
| Sponsor Request - Conflict of Interest | 0 | 2 |
| Personal Reasons | 1 | 4 |
Baseline Characteristics
| Description | |
|---|---|
| Bimatoprost 0.03% Solution | No text entered. |
| Vehicle Solution | No text entered. |
| Bimatoprost 0.03% Solution | Vehicle Solution | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
137 | 141 | 278 |
|
Age, Customized [units: participants] |
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| <45 years | 44 | 43 | 87 |
| Between 45 and 65 years | 82 | 88 | 170 |
| >65 years | 11 | 10 | 21 |
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Gender [units: participants] |
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| Female | 134 | 136 | 270 |
| Male | 3 | 5 | 8 |
Outcome Measures
| 1. Primary: | Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 [ Week 16 ] |
| 2. Primary: | Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment) [ Week 20 ] |
| 3. Secondary: | Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Week 16 ] |
| 4. Secondary: | Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [ Week 20 ] |
| 5. Secondary: | Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Week 16 ] |
| 6. Secondary: | Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [ Week 20 ] |
| 7. Secondary: | Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Week 16 ] |
| 8. Secondary: | Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) [ Week 20 ] |
| 9. Other Pre-specified: | Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16 [ Week 16 ] |
| 10. Other Pre-specified: | Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment) [ Week 20 ] |
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. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| None |
| Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 192024-032 |
| Study First Received: | June 5, 2008 |
| Results First Received: | January 14, 2009 |
| Last Updated: | March 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00693420 History of Changes |
| Health Authority: | United States: Food and Drug Administration |