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This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimatoprost ophthalmic solution 0.005% | Experimental | bimatoprost ophthalmic sterile solution 0.005% |
|
| bimatoprost ophthalmic solution 0.015% | Experimental | bimatoprost ophthalmic sterile solution 0.015% |
|
| bimatoprost ophthalmic solution 0.03% | Active Comparator | bimatoprost ophthalmic solution 0.03% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost ophthalmic solution 0.005% | Drug | One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eyelash Length at Month 3 | Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Upper Eyelash Thickness at Month 3 | Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness. |
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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 |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost Ophthalmic Solution 0.005% | bimatoprost ophthalmic sterile solution 0.005% |
| FG001 | Bimatoprost Ophthalmic Solution 0.015% | bimatoprost ophthalmic sterile solution 0.015% |
| FG002 | Bimatoprost Ophthalmic Solution 0.03% | bimatoprost ophthalmic solution 0.03% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost Ophthalmic Solution 0.005% | bimatoprost ophthalmic sterile solution 0.005% |
| BG001 | Bimatoprost Ophthalmic Solution 0.015% | bimatoprost ophthalmic sterile solution 0.015% |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change From Baseline in Eyelash Length at Month 3 | Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length. | Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one-follow-up visit. (Note that one subject in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.) | Posted | Mean | Standard Deviation | millimeters (mm) | Baseline, Month 3 |
|
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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 0.005% | bimatoprost ophthalmic sterile solution 0.005% |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelids Pruritus | Eye disorders | MedDRA (13.0) | 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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| bimatoprost ophthalmic solution 0.015% | Drug | One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) |
|
| bimatoprost ophthalmic solution 0.03% | Drug | One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) |
|
|
| Baseline, Month 3 |
| Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3 | Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening. | Baseline, Month 3 |
| Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3 | Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3. | Month 3 |
| Change From Baseline in Overall Eyelash Satisfaction at Month 3 | Change from baseline at Month 3 in question 3 "overall, how satisfied are you with your eyelashes?" Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline. | Baseline, Month 3 |
| Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3 | Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline. | Baseline, Month 3 |
| Treatment Satisfaction Questionnaire Score at Month 3 | The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best). | Month 3 |
| BG002 | Bimatoprost Ophthalmic Solution 0.03% | bimatoprost ophthalmic solution 0.03% |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Bimatoprost Ophthalmic Solution 0.015% |
bimatoprost ophthalmic sterile solution 0.015% |
| OG002 | Bimatoprost Ophthalmic Solution 0.03% | bimatoprost ophthalmic solution 0.03% |
|
|
| Secondary | Change From Baseline in Upper Eyelash Thickness at Month 3 | Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness. | Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.) | Posted | Mean | Standard Deviation | Millimeters squared (mm^2) | Baseline, Month 3 |
|
|
|
| Secondary | Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3 | Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening. | Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.) | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Month 3 |
|
|
|
| Secondary | Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3 | Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3. | Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. | Posted | Number | Percentage of Subjects | Month 3 |
|
|
|
| Secondary | Change From Baseline in Overall Eyelash Satisfaction at Month 3 | Change from baseline at Month 3 in question 3 "overall, how satisfied are you with your eyelashes?" Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline. | Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 3 |
|
|
|
| Secondary | Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3 | Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline. | Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, Month 3 |
|
|
|
| Secondary | Treatment Satisfaction Questionnaire Score at Month 3 | The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best). | Modified Intent-to-Treat: All randomized subjects who were treated with the intended study medication and completed at least one follow-up visit.(Note: 2 subjects in the Bim 0.015% treatment group, 1 subject in the Bim 0.005% treatment group, and 1 subject in the Bim 0.03% treatment group did not have Month 3 visit data for this outcome measure) | Posted | Mean | Standard Deviation | Scores on a Scale | Month 3 |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Bimatoprost Ophthalmic Solution 0.015% | bimatoprost ophthalmic sterile solution 0.015% | 1 | 34 | 7 | 34 |
| EG002 | Bimatoprost Ophthalmic Solution 0.03% | bimatoprost ophthalmic solution 0.03% | 0 | 34 | 2 | 34 |
| Eyelid Pain | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
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 |
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