Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-03 @ 3:29 PM
Study NCT ID:
NCT03226769
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 30', 'eventGroups': [{'id': 'EG000', 'title': 'Thermalon', 'description': 'Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TrueTear™', 'description': 'Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 2, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 20.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thermalon', 'description': 'Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.'}, {'id': 'OG001', 'title': 'TrueTear™', 'description': 'Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.'}], 'classes': [{'title': 'Computer Usage', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Reading', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Leisure Activities', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Social Activities', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Driving', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Outdoor Activities', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of Outdoor Activities', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Time Spent to Take Care of Eyes', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Bothered With Amount of Time Taking Care of Eyes', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Bothered by Appearance', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9788', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Computer Usage', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.6571', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Reading', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.4710', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Leisure Activities', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.7360', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Social Activities', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.4999', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Driving', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.1159', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Outdoor Activities', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.4567', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Frequency of Outdoor Activities', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.3439', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Time Spent to Take Care of Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.3331', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Bothered With Amount of Time Taking Care of Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.4774', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Bothered by Appearance', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Day 30', 'description': 'MGD impact questionnaire includes 10 questions about the impacts a participant may experience associated with MGD. Participants were asked to rate how much they have been affected by MGD symptoms in past 7 days. Question/s (Qs) 1-6 (computer usage, reading, leisure activities, social activities, driving and outdoor activities) were rated on a scale of 1=no difficulty to 5=a lot of difficulty. Q7 (frequency of outdoor activities) was rated on scale of 1=never to 5=all the time. If participants did not experience a particular impact, they chose 0=NA for Qs 1-7. Q8 (time spent to take care of eyes) was rated on scale 0-4, where 0=no time at all to 4=a lot of time, Qs 9-10 (bothered with amount of time taking care of eyes and bothered by appearance) were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in MGD Symptoms Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thermalon', 'description': 'Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.'}, {'id': 'OG001', 'title': 'TrueTear™', 'description': 'Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.'}], 'classes': [{'title': 'Red Eyes', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Blurred Vision', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Dry Eyes', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Itchy Eyes', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Burning Eyes', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Gritty Eyes', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Painful Eyes', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Watery Eyes', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Eyelids', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Red Eyelids', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Crusty Eyelids', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5457', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Red Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.9786', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Blurred Vision', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.3894', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Dry Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.0591', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Itchy Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.1818', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Burning Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.4284', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Gritty Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.1051', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Painful Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.7998', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Watery Eyes', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.1229', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Swollen Eyelids', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.3907', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Red Eyelids', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}, {'pValue': '0.0336', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistically significant (p \\< 0.05) and trending significant (p \\< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.', 'groupDescription': 'Crusty Eyelids', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0) to Day 30', 'description': 'MGD symptom questionnaire included 11 questions about the symptoms the participant may experience associated with MGD. The participant was asked to rate how much they experienced certain MGD symptoms and the severity of the symptoms over the past 24 hours on a scale of 0 to 4, where 0 = not at all, 1 = a little, 2 = somewhat, 3=quite a bit, 4 = very. A higher score within each question represented increased severity of the indicated symptom. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thermalon', 'description': 'Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.'}, {'id': 'FG001', 'title': 'TrueTear™', 'description': 'Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Thermalon', 'description': 'Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.'}, {'id': 'BG001', 'title': 'TrueTear™', 'description': 'Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '12.16', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '13.91', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '12.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score', 'classes': [{'title': 'Computer Usage', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '2.0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '2.1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Reading', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.0', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2.3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Leisure Activities', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '2.3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Social Activities', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Driving', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.1', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.0', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Outdoor Activities', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1.6', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.7', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Frequency of Outdoor Activities', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.8', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1.9', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Time Spent to Take Care of Eyes', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.4', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Bothered With Amount of Time Taking Care of Eyes', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.9', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Bothered by Appearance', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'description': 'MGD impact questionnaire includes 10 questions about impacts participant may experience associated with MGD. Question/s (Qs) 1-6 were rated on a scale of 1=no difficulty to 5=lot of difficulty. Q7 was rated on scale of 1=never to 5=all the time. If participants did not experience particular impact, they chose 0=Not applicable (NA) for Qs 1-7. Q8 was rated on scale 0-4, where 0=no time at all to 4=lot of time, Qs 9-10 were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. For additional scale information see Outcome Measure section.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'MGD Symptoms Questionnaire Score', 'classes': [{'title': 'Red Eyes', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Blurred Vision', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.2', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Dry Eyes', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.5', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.5', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Itchy Eyes', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1.6', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.9', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Burning Eyes', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Gritty Eyes', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.8', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Painful Eyes', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.9', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.9', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Watery Eyes', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.3', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Swollen Eyelids', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Red Eyelids', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.9', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Crusty Eyelids', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.0', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'description': 'MGD symptom questionnaire included 11 questions about the symptoms the participant may experience associated with MGD. The participant was asked to rate how much they experienced certain MGD symptoms and the severity of the symptoms over the past 24 hours on a scale of 0 to 4, where 0 = not at all, 1 = a little, 2 = somewhat, 3=quite a bit, 4 = very. A higher score within each question represented increased severity of the indicated symptom. For additional scale information see Outcome Measure section.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-25', 'size': 1292796, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-08T12:12', 'hasProtocol': False}, {'date': '2017-06-01', 'size': 1874664, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-08T12:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2018-10-08', 'completionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-08', 'studyFirstSubmitDate': '2017-07-20', 'dispFirstSubmitQcDate': '2018-10-08', 'resultsFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2017-07-20', 'dispFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-08', 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Meibomian Gland Dysfunction (MGD) Impact Questionnaire Score', 'timeFrame': 'Baseline (Day 0) to Day 30', 'description': 'MGD impact questionnaire includes 10 questions about the impacts a participant may experience associated with MGD. Participants were asked to rate how much they have been affected by MGD symptoms in past 7 days. Question/s (Qs) 1-6 (computer usage, reading, leisure activities, social activities, driving and outdoor activities) were rated on a scale of 1=no difficulty to 5=a lot of difficulty. Q7 (frequency of outdoor activities) was rated on scale of 1=never to 5=all the time. If participants did not experience a particular impact, they chose 0=NA for Qs 1-7. Q8 (time spent to take care of eyes) was rated on scale 0-4, where 0=no time at all to 4=a lot of time, Qs 9-10 (bothered with amount of time taking care of eyes and bothered by appearance) were rated on scale 0-4, with 0=not at all bothered to 4=very bothered. Higher scores represented greater impact. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in MGD Symptoms Questionnaire Score', 'timeFrame': 'Baseline (Day 0) to Day 30', 'description': 'MGD symptom questionnaire included 11 questions about the symptoms the participant may experience associated with MGD. The participant was asked to rate how much they experienced certain MGD symptoms and the severity of the symptoms over the past 24 hours on a scale of 0 to 4, where 0 = not at all, 1 = a little, 2 = somewhat, 3=quite a bit, 4 = very. A higher score within each question represented increased severity of the indicated symptom. A negative change from baseline indicates improvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Meibomian Glands', 'Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry eye disease or Meibomian Gland Disease as evaluated by Standard Participant Evaluation for Dryness (SPEED) score, Schirmer test, Tear film breakup time and other applicable objective measures at the Screening and Baseline Visits.\n* Use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or Meibomian Gland Disease within one year of the Screening Visit.\n\nExclusion Criteria:\n\n* Chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding.\n* History of nasal or sinus surgery.\n* Vascularized polyp, deviated septum or severe nasal airway obstruction at the Screening visit.\n* Intraocular and extraocular surgery in either eye within three months of the Screening Visit or refractive surgery within twelve months of the Screening Visit.\n* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head.'}, 'identificationModule': {'nctId': 'NCT03226769', 'briefTitle': 'Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Prospective, Open-Label, Randomized, Proof of Concept Study Exploring Application of TrueTear™ for the Treatment of Meibomian Gland Disease', 'orgStudyIdInfo': {'id': 'OCUN-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thermalon', 'description': 'Participants received application of Thermalon dry eye compress on Days 0 and 7 followed by daily use as per label instructions.', 'interventionNames': ['Device: Thermalon Dry Eye Compress']}, {'type': 'EXPERIMENTAL', 'label': 'TrueTear™', 'description': 'Participants received TrueTear™ device intranasally for approximately 8 minutes on Day 0, for approximately 3 minutes on Day 7 followed by daily use of TrueTear™ per participant guide.', 'interventionNames': ['Device: TrueTear™']}], 'interventions': [{'name': 'TrueTear™', 'type': 'DEVICE', 'description': 'Intranasal application of TrueTear™ device for approximately 8 minutes at Day 0, for approximately 3 minutes at Day 7 and then daily use of TrueTear™ per participant guide.', 'armGroupLabels': ['TrueTear™']}, {'name': 'Thermalon Dry Eye Compress', 'type': 'DEVICE', 'description': 'Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.', 'armGroupLabels': ['Thermalon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Gail Torkildsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'mdlasik@comcast.net'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}