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The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimatoprost ophthalmic solution 0.03% | Active Comparator | One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
|
| bimatoprost vehicle solution | Placebo Comparator | One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost ophthalmic solution 0.03% | Drug | One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall | Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score | The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement. | Baseline, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coral Gables | Florida | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost Ophthalmic Solution 0.03% | One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
| FG001 | Bimatoprost Vehicle Solution | One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost Ophthalmic Solution 0.03% | One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
| BG001 | Bimatoprost Vehicle Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall | Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported. | Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment. | Posted | Number | Percentage of participants | Week 16 |
|
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Treatment-emergent adverse events are presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bimatoprost Ophthalmic Solution 0.03% | One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
| bimatoprost vehicle solution | Drug | One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
|
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Bimatoprost Vehicle Solution | One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
|
|
| Secondary | Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score | The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement. | Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment. | Posted | Number | Percentage of participants | Baseline, Week 16 |
|
|
|
| 0 |
| 44 |
| 1 |
| 44 |
| EG001 | Bimatoprost Vehicle Solution | One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. | 0 | 44 | 3 | 44 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |