Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-07 @ 11:04 AM
Study NCT ID:
NCT02680158
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal 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': 'Day 0', 'description': 'Safety population included all randomized participants who were exposed to study applications.', 'eventGroups': [{'id': 'EG000', 'title': 'Oculeve Intranasal', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 4, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': 'Sham device (control), intranasal application for approximately 3 minutes on Day 0', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Oculeve Extranasal', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Slight transient lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent nose itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Stimulated Tear Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oculeve Intranasal', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham device (control), intranasal application for approximately 3 minutes on Day 0'}, {'id': 'OG002', 'title': 'Oculeve Extranasal', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '10.70', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '7.34', 'groupId': 'OG001'}, {'value': '9.5', 'spread': '8.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 post-application', 'description': 'Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'The FAS population included all randomized participants who were exposed to study application.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oculeve Intranasal', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham device (control), intranasal application for approximately 3 minutes on Day 0'}, {'id': 'OG002', 'title': 'Oculeve Extranasal', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0'}], 'classes': [{'title': 'Device-related AEs (Ocular)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Device-related AEs (Non-ocular)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Safety population included all randomized participants who were exposed to study application.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Corrected Distance Visual Acuity', 'timeFrame': '1-Day', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Slit Lamp Biomicroscopy', 'timeFrame': '1-Day', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pulse Rate', 'timeFrame': '1-Day', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Oxygen Saturation', 'timeFrame': '1-Day', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Pressure', 'timeFrame': '1-Day', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1 - Intranasal : Extranasal : Sham', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.'}, {'id': 'FG001', 'title': 'Sequence 2 - Intranasal : Sham : Extranasal', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.'}, {'id': 'FG002', 'title': 'Sequence 3 - Extranasal: Intranasal: Sham', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.'}, {'id': 'FG003', 'title': 'Sequence 4 - Extranasal : Sham : Intranasal', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.'}, {'id': 'FG004', 'title': 'Sequence 5 - Sham : Intranasal : Extranasal', 'description': 'Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.'}, {'id': 'FG005', 'title': 'Sequence 6 - Sham : Extranasal : Intranasal', 'description': 'Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG002', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG003', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG004', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG005', 'numUnits': '8', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG002', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG003', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG004', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG005', 'numUnits': '8', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}, {'units': 'eyes', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'All participants who received oculeve device, intranasal (test) application, extranasal (control) and sham device, intranasal (control) application, for approximately 3 minutes on Day 0.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '13.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'eyes', 'populationDescription': 'All randomized participants who were exposed to study application.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Three way cross-over study with 6 sequences.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2017-04-07', 'completionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2016-01-21', 'dispFirstSubmitQcDate': '2017-04-07', 'resultsFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2016-02-08', 'dispFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-04', 'studyFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Corrected Distance Visual Acuity', 'timeFrame': '1-Day'}, {'measure': 'Slit Lamp Biomicroscopy', 'timeFrame': '1-Day'}, {'measure': 'Pulse Rate', 'timeFrame': '1-Day'}, {'measure': 'Oxygen Saturation', 'timeFrame': '1-Day'}, {'measure': 'Blood Pressure', 'timeFrame': '1-Day'}], 'primaryOutcomes': [{'measure': 'Acute Stimulated Tear Production', 'timeFrame': 'Day 0 post-application', 'description': 'Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.'}, {'measure': 'Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)', 'timeFrame': 'Day 0', 'description': 'An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome', 'Keratoconjunctivitis Sicca']}, 'referencesModule': {'references': [{'pmid': '30472141', 'type': 'DERIVED', 'citation': 'Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.', 'detailedDescription': 'This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with aqueous tear deficiency\n* Literate, able to speak English or Spanish, and able to complete questionnaires independently\n* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol\n\nExclusion Criteria:\n\n* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding\n* Nasal or sinus surgery including nasal cautery or significant trauma\n* Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device\n* Diagnosis of epilepsy\n* Corneal transplant in either or both eyes\n* Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit\n* A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit'}, 'identificationModule': {'nctId': 'NCT02680158', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oculeve, Inc.'}, 'officialTitle': 'A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye', 'orgStudyIdInfo': {'id': 'OCUN-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1-Intranasal: Extranasal: Sham', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.', 'interventionNames': ['Device: Oculeve Intranasal', 'Device: Sham', 'Device: Oculeve Extranasal']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2-Intranasal: Sham: Extranasal', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.', 'interventionNames': ['Device: Oculeve Intranasal', 'Device: Sham', 'Device: Oculeve Extranasal']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3-Extranasal: Intranasal: Sham', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.', 'interventionNames': ['Device: Oculeve Intranasal', 'Device: Sham', 'Device: Oculeve Extranasal']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4-Extranasal: Sham: Intranasal', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.', 'interventionNames': ['Device: Oculeve Intranasal', 'Device: Sham', 'Device: Oculeve Extranasal']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5-Sham: Intranasal: Extranasal', 'description': 'Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.', 'interventionNames': ['Device: Oculeve Intranasal', 'Device: Sham', 'Device: Oculeve Extranasal']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6-Sham: Extranasal: Intranasal', 'description': 'Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application.', 'interventionNames': ['Device: Oculeve Intranasal', 'Device: Sham', 'Device: Oculeve Extranasal']}], 'interventions': [{'name': 'Oculeve Intranasal', 'type': 'DEVICE', 'description': 'Oculeve device, intranasal (test) application for approximately 3 minutes.', 'armGroupLabels': ['Sequence 1-Intranasal: Extranasal: Sham', 'Sequence 2-Intranasal: Sham: Extranasal', 'Sequence 3-Extranasal: Intranasal: Sham', 'Sequence 4-Extranasal: Sham: Intranasal', 'Sequence 5-Sham: Intranasal: Extranasal', 'Sequence 6-Sham: Extranasal: Intranasal']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'Sham device (control), intranasal application for approximately 3 minutes.', 'armGroupLabels': ['Sequence 1-Intranasal: Extranasal: Sham', 'Sequence 2-Intranasal: Sham: Extranasal', 'Sequence 3-Extranasal: Intranasal: Sham', 'Sequence 4-Extranasal: Sham: Intranasal', 'Sequence 5-Sham: Intranasal: Extranasal', 'Sequence 6-Sham: Extranasal: Intranasal']}, {'name': 'Oculeve Extranasal', 'type': 'DEVICE', 'description': 'Oculeve device, extranasal (control) application for approximately 3 minutes.', 'armGroupLabels': ['Sequence 1-Intranasal: Extranasal: Sham', 'Sequence 2-Intranasal: Sham: Extranasal', 'Sequence 3-Extranasal: Intranasal: Sham', 'Sequence 4-Extranasal: Sham: Intranasal', 'Sequence 5-Sham: Intranasal: Extranasal', 'Sequence 6-Sham: Extranasal: Intranasal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Eye Care Group', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Consultants', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Michelle Senchyna', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oculeve, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}