Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00693420
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2008-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069580', 'term': 'Bimatoprost'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '(714)246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bimatoprost 0.03% Solution', 'otherNumAffected': 40, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vehicle Solution', 'otherNumAffected': 22, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pinguecula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eyelids pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blepharal Papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin Hyper pigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Squamous cell carcinoma of the skin (back)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 141, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '50.4', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '69.3', 'groupId': 'OG000'}, {'value': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (Primary Endpoint)', 'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \\[minimal\\], 2 \\[moderate\\], 3 \\[marked\\], 4 \\[very marked\\])', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'title': 'Day 1 (Baseline)', 'categories': [{'measurements': [{'value': '5.79', 'spread': '0.815', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '0.814', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.327', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.327', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.371', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.382', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.559', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.396', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.722', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.425', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (Primary Endpoint)', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.908', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.425', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Upper eyelash length technologically measured in millimeters', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '0.831', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.431', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 20', 'description': 'Upper eyelash length technologically measured in millimeters', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'title': 'Day 1 (Baseline)', 'categories': [{'measurements': [{'value': '16.16', 'spread': '8.089', 'groupId': 'OG000'}, {'value': '16.66', 'spread': '7.787', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.94', 'spread': '3.651', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '3.161', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.62', 'spread': '4.031', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '3.639', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.48', 'spread': '5.148', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '4.189', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '9.30', 'spread': '7.328', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '4.398', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (Primary Endpoint)', 'categories': [{'measurements': [{'value': '12.21', 'spread': '8.381', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '3.984', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': '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.', 'unitOfMeasure': 'percentage of AOI (in pixels)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'title': 'Day 1 (Baseline)', 'categories': [{'measurements': [{'value': '4.18', 'spread': '0.788', 'groupId': 'OG000'}, {'value': '4.16', 'spread': '0.789', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.466', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.550', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.829', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.728', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '1.107', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.943', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.48', 'spread': '1.207', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.939', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (Primary Endpoint)', 'categories': [{'measurements': [{'value': '-1.89', 'spread': '1.253', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '1.074', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': '"Overall, how satisfied are you with your eyelashes?"\n\nPossible Answers on a 5 point scale as follows:\n\n1. \\- Very Satisfied\n2. \\- Satisfied\n3. \\- Neutral\n4. \\- Unsatisfied\n5. \\- Very Unsatisfied', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 20', 'description': 'The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \\[minimal\\], 2 \\[moderate\\], 3 \\[marked\\], 4 \\[very marked\\])', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '11.16', 'spread': '7.051', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '4.470', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 20', 'description': '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.', 'unitOfMeasure': 'percentage of AOI (in pixels)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'title': 'Day 1 (Baseline)', 'categories': [{'measurements': [{'value': '105.67', 'spread': '20.349', 'groupId': 'OG000'}, {'value': '102.82', 'spread': '18.161', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '-2.97', 'spread': '8.102', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '8.233', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-5.10', 'spread': '10.327', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '9.363', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-9.11', 'spread': '11.824', 'groupId': 'OG000'}, {'value': '-2.46', 'spread': '11.249', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-16.68', 'spread': '13.585', 'groupId': 'OG000'}, {'value': '-4.22', 'spread': '11.073', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (Primary Endpoint)', 'categories': [{'measurements': [{'value': '-20.15', 'spread': '16.051', 'groupId': 'OG000'}, {'value': '-3.57', 'spread': '10.491', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)', 'unitOfMeasure': 'intensity unit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.12', 'spread': '14.943', 'groupId': 'OG000'}, {'value': '-5.51', 'spread': '10.789', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 20', 'description': 'Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)', 'unitOfMeasure': 'intensity unit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'OG001', 'title': 'Vehicle Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.06', 'spread': '1.345', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '1.128', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 20', 'description': '"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)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'FG001', 'title': 'Vehicle Solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor Request - Conflict of Interest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimatoprost 0.03% Solution'}, {'id': 'BG001', 'title': 'Vehicle Solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Between 45 and 65 years', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}, {'title': '>65 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-26', 'studyFirstSubmitDate': '2008-06-05', 'resultsFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-26', 'studyFirstPostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': '"Overall, how satisfied are you with your eyelashes?"\n\nPossible Answers on a 5 point scale as follows:\n\n1. \\- Very Satisfied\n2. \\- Satisfied\n3. \\- Neutral\n4. \\- Unsatisfied\n5. \\- Very Unsatisfied'}, {'measure': 'Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)', 'timeFrame': 'Baseline to Week 20', 'description': '"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)'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \\[minimal\\], 2 \\[moderate\\], 3 \\[marked\\], 4 \\[very marked\\])'}, {'measure': 'Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)', 'timeFrame': 'Baseline to Week 20', 'description': 'The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 \\[minimal\\], 2 \\[moderate\\], 3 \\[marked\\], 4 \\[very marked\\])'}], 'secondaryOutcomes': [{'measure': 'Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Upper eyelash length technologically measured in millimeters'}, {'measure': 'Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)', 'timeFrame': 'Baseline to Week 20', 'description': 'Upper eyelash length technologically measured in millimeters'}, {'measure': 'Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': '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.'}, {'measure': 'Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)', 'timeFrame': 'Baseline to Week 20', 'description': '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.'}, {'measure': 'Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)'}, {'measure': 'Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)', 'timeFrame': 'Baseline to Week 20', 'description': 'Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)'}]}, 'conditionsModule': {'conditions': ['Eyelashes']}, 'referencesModule': {'references': [{'pmid': '23873891', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dissatisfaction with eyelash prominence,\n* Eyelash prominence assessment of minimal or moderate,\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Subjects without visible lashes,\n* Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,\n* Any eye disease or abnormality,\n* Eye surgery,\n* Permanent eyeliner,\n* Eyelash implants,\n* Eyelash extension application,\n* Any use of eyelash growth products within 6 months of study entry,\n* Treatments that may effect hair growth,\n* Subjects requiring eye drop medications for glaucoma,\n* Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.'}, 'identificationModule': {'nctId': 'NCT00693420', 'briefTitle': 'Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '192024-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bimatoprost 0.03% solution', 'interventionNames': ['Drug: Bimatoprost 0.03% sterile solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Vehicle solution', 'interventionNames': ['Drug: vehicle sterile solution']}], 'interventions': [{'name': 'Bimatoprost 0.03% sterile solution', 'type': 'DRUG', 'otherNames': ['LUMIGAN®'], 'description': 'Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.', 'armGroupLabels': ['1']}, {'name': 'vehicle sterile solution', 'type': 'DRUG', 'description': 'Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Allergan, Inc.'}}}}