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This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost 0.03% Followed by Bimatoprost 0.03% | Experimental | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
|
| Bimatoprost 0.03% Followed by Vehicle | Other | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
|
| Vehicle Followed by Bimatoprost 0.03% | Other | Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.03% solution | Drug | Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treatment Responders at Month 4 | Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15. | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Upper Eyelash Length at Month 4 | Change from Baseline to in upper eyelash length at Month 4, 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 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4 | Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence. | Month 4 |
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 |
|---|---|---|---|
| 26060513 | Derived | Wirta D, Baumann L, Bruce S, Ahluwalia G, Weng E, Daniels S. Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects. J Clin Aesthet Dermatol. 2015 Apr;8(4):11-20. | |
| 24643895 | Derived | Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost 0.03% Followed by Bimatoprost 0.03% | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| FG001 | Bimatoprost 0.03% Followed by Vehicle | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| FG002 | Vehicle Followed by Bimatoprost 0.03% | Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (0 to 6 Months) |
| |||||||||||||
| Treatment Period 2 (6 to 12 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.03% Followed by Bimatoprost 0.03% | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| 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 Treatment Responders at Month 4 | Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15. | Intent-to-Treat: All randomized subjects | Posted | Number | Percentage of Subjects | Month 4 |
|
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The Safety Population included all subjects who received at least one dose of study medication and was used to analyze serious adverse events (SAEs) and adverse events (AEs). SAEs/AEs are reported by arm randomized, not by treatment received.
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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% Followed by Bimatoprost 0.03% | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA Version 14.0 | 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 |
|---|---|
| D007039 | Hypotrichosis |
| ID | Term |
|---|---|
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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|
| Vehicle solution | Drug | Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). |
|
|
| Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 | Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness. | Baseline, Month 4 |
| Change From Baseline in Upper Eyelash Darkness at Month 4 | Change from baseline in upper eyelash darkness at Month 4 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. A negative number value change from baseline indicated increased eyelash darkening. | Baseline, Month 4 |
| London |
| England |
| United Kingdom |
| NOT COMPLETED |
|
| BG001 | Bimatoprost 0.03% Followed by Vehicle | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| BG002 | Vehicle Followed by Bimatoprost 0.03% | Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Vehicle | Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). |
|
|
| Secondary | Change From Baseline in Upper Eyelash Length at Month 4 | Change from Baseline to in upper eyelash length at Month 4, 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. | Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure | Posted | Mean | Standard Deviation | Millimeters (mm) | Baseline, Month 4 |
|
|
|
| Secondary | Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 | Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness. | Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure | Posted | Mean | Standard Deviation | Millimeters squared (mm^2) | Baseline, Month 4 |
|
|
|
| Secondary | Change From Baseline in Upper Eyelash Darkness at Month 4 | Change from baseline in upper eyelash darkness at Month 4 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. A negative number value change from baseline indicated increased eyelash darkening. | Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure | Posted | Mean | Standard Deviation | Eyelash Intensity Units | Baseline, Month 4 |
|
|
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| Other Pre-specified | Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4 | Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence. | Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure | Posted | Number | Percentage of Participants | Month 4 |
|
|
|
| 20 |
| 214 |
| 75 |
| 214 |
| EG001 | Bimatoprost 0.03% Followed by Vehicle | Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin. | 3 | 60 | 21 | 60 |
| EG002 | Vehicle Followed by Bimatoprost 0.03% | Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin. | 9 | 92 | 36 | 92 |
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| Gastrointestinal Inflammation | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Chest Pain | General disorders | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Bronchitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Lung Carcinoma Cell Type Unspecified Stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Migraine | Nervous system disorders | MedDRA Version 14.0 | Non-systematic Assessment | Not related to study treatment |
|
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Vaginal Prolapse | Reproductive system and breast disorders | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Breast Reconstruction | Surgical and medical procedures | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Breast Cellulitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
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| Pneumonia | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment | Not related to study treatment |
|
| Punctate Keratitis | Eye disorders | MedDRA Version 14.0 | Systematic Assessment |
|
| Eyelids Pruritus | Eye disorders | MedDRA Version 14.0 | Non-systematic Assessment |
|
| Erythema of Eyelid | Eye disorders | MedDRA Version 14.0 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 14.0 | Non-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 |
| D004364 | Pharmaceutical Preparations |