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This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bimatoprost 0.03% solution |
|
| 2 | Placebo Comparator | Vehicle solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.03% sterile solution | Drug | Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 | The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) | Baseline to Week 16 |
| Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment) | The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) | Baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Upper eyelash length technologically measured in millimeters | Baseline to Week 16 |
| Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16 | "Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows:
| Baseline to Week 16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23873891 | Derived | Fagien S, Walt JG, Carruthers J, Cox SE, Wirta D, Weng E, Beddingfield FC 3rd. Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study. Aesthet Surg J. 2013 Aug 1;33(6):789-98. doi: 10.1177/1090820X13495887. Epub 2013 Jul 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost 0.03% Solution | |
| FG001 | Vehicle Solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.03% Solution | |
| BG001 | Vehicle Solution | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 | The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) | Intent to Treat Population | Posted | Number | Percentage of participants | Baseline to Week 16 |
|
|
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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 0.03% Solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of the skin (back) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | MedDRA | Non-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 |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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| vehicle sterile solution | Drug | Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily |
|
Upper eyelash length technologically measured in millimeters |
| Baseline to Week 20 |
| Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. | Baseline to Week 16 |
| Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. | Baseline to Week 20 |
| Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) | Baseline to Week 16 |
| Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) | Baseline to Week 20 |
| Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment) |
"Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied) |
| Baseline to Week 20 |
| Vancouver |
| British Columbia |
| Canada |
| Withdrawal by Subject |
|
| Protocol Violation |
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| Sponsor Request - Conflict of Interest |
|
| Personal Reasons |
|
Total of all reporting groups
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Upper eyelash length technologically measured in millimeters | Intent to Treat Population | Posted | Mean | Standard Deviation | millimeters | Baseline to Week 16 |
|
|
|
| Secondary | Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Upper eyelash length technologically measured in millimeters | Intent to Treat Population | Posted | Mean | Standard Deviation | millimeters | Baseline to Week 20 |
|
|
|
| Secondary | Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. | Intent to Treat Population | Posted | Mean | Standard Deviation | percentage of AOI (in pixels) | Baseline to Week 16 |
|
|
|
| Other Pre-specified | Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16 | "Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows:
| Intent to Treat Population | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 16 |
|
|
|
| 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) | The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked]) | Intent to Treat Population | Posted | Number | Percentage of participants | Baseline to Week 20 |
|
|
|
| Secondary | Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm. | Intent to Treat Population | Posted | Mean | Standard Deviation | percentage of AOI (in pixels) | Baseline to Week 20 |
|
|
|
| Secondary | Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 | Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) | Intent to Treat Population | Posted | Mean | Standard Deviation | intensity unit | Baseline to Week 16 |
|
|
|
| Secondary | Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment) | Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white) | Intent to Treat Population | Posted | Mean | Standard Deviation | intensity unit | Baseline to Week 20 |
|
|
|
| Other Pre-specified | Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment) | "Overall, how satisfied are you with your eyelashes?" Possible Answers on a 5 point scale as follows: (1 - Very Satisfied; 2 - Satisfied; 3 - Neutral; 4 - Unsatisfied; 5 - Very Unsatisfied) | Intent to Treat Population | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 20 |
|
|
|
| 1 |
| 40 |
| EG001 | Vehicle Solution | 2 | 22 |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA | Non-systematic Assessment |
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| Pinguecula | Eye disorders | MedDRA | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA | Non-systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA | Non-systematic Assessment |
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| Erythema of eyelid | Eye disorders | MedDRA | Non-systematic Assessment |
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| Eyelids pruritus | Eye disorders | MedDRA | Non-systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Blepharal Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Skin Hyper pigmentation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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At least ninety (90) days prior to any proposed submission for publication or presentation of Study data or other findings related to the Study, the Institution will provide the Sponsor with a manuscript of such submission(s) for review and comment.
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Week 12 |
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| Week 16 (Primary Endpoint) |
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