Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT03688802
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D059085', 'term': 'Nasal Sprays'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D000336', 'term': 'Aerosols'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jnau@oysterpointrx.com', 'phone': '609-382-9035', 'title': 'Jeffrey Nau', 'organization': 'Oyster Point Pharma, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of study drug administration to the last study visit (pre to post treatment 1 day).', 'eventGroups': [{'id': 'EG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/mL', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (vehicle control) nasal spray', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'TEAE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Goblet Cell Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01: OC-01 (varenicline) nasal spray'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo Vehicle ) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.8', 'spread': '30.20', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '1.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Goblet Cell Perimeter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01: OC-01 (varenicline) nasal spray'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo Vehicle ) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.7', 'spread': '5.79', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics.'}, {'type': 'PRIMARY', 'title': 'Change in Meibomian Gland Area, Upper Lid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01: OC-01 (varenicline) nasal spray'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo Vehicle ) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '118.6', 'groupId': 'OG000'}, {'value': '-143.2', 'spread': '154.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Meibomian Gland Area, Lower Lid.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01: OC-01 (varenicline) nasal spray'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo Vehicle ) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.9', 'spread': '88.1', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '95.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Meibomian Gland Perimeter, Upper Lid.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01: OC-01 (varenicline) nasal spray'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo Vehicle ) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '6.15', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '-19.2', 'spread': '22.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Meibomian Gland Perimeter, Lower Lid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01: OC-01 (varenicline) nasal spray'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Placebo Vehicle ) nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '19.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.', 'unitOfMeasure': 'um', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in the ITT population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OC-01 (Varenicline) Nasal Spray, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/mL\n\nOC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray'}, {'id': 'FG001', 'title': 'Placebo (Vehicle Control) Nasal Spray', 'description': 'Placebo (vehicle control) nasal spray\n\nPlacebo (vehicle control) nasal spray: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OC-01, 1.2 mg/mL', 'description': 'OC-01: OC-01 (varenicline) nasal spray'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo (vehicle) nasal spray: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '13.79', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '13.46', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '13.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Schirmer's Test Score", 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '4.42', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '3.89', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '4.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Schirmer's Test Score from 0-35 mm where a higher score is indicative of a better outcome.", 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-26', 'size': 833197, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-10T10:43', 'hasProtocol': True}, {'date': '2020-07-01', 'size': 2397738, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-19T14:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2021-01-26', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2018-09-26', 'dispFirstSubmitQcDate': '2021-11-30', 'resultsFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2018-09-27', 'dispFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-30', 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Goblet Cell Area', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.'}, {'measure': 'Mean Change in Goblet Cell Perimeter', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.'}, {'measure': 'Change in Meibomian Gland Area, Upper Lid', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome'}, {'measure': 'Mean Change in Meibomian Gland Area, Lower Lid.', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.'}, {'measure': 'Mean Change in Meibomian Gland Perimeter, Upper Lid.', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.'}, {'measure': 'Mean Change in Meibomian Gland Perimeter, Lower Lid', 'timeFrame': 'Baseline (pre-treatment), 1 day (post treatment)', 'description': 'Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'referencesModule': {'references': [{'pmid': '35653029', 'type': 'DERIVED', 'citation': 'Dieckmann GM, Cox SM, Lopez MJ, Ozmen MC, Yavuz Saricay L, Bayrakutar BN, Binotti WW, Henry E, Nau J, Hamrah P. A Single Administration of OC-01 (Varenicline Solution) Nasal Spray Induces Short-Term Alterations in Conjunctival Goblet Cells in Patients with Dry Eye Disease. Ophthalmol Ther. 2022 Aug;11(4):1551-1561. doi: 10.1007/s40123-022-00530-x. Epub 2022 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.', 'detailedDescription': "This was a Phase 2, single-center, randomized, masked (including all subjects, investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in stimulating goblet cell and Meibomian gland function in in adult subjects with DED. Approximately 45 subjects at least 18 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria were planned to be randomized to receive a single application of 0.2% (1.2 mg/mL) OC-01 or placebo"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1.\n\nExclusion Criteria:\n\n* Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1\n* Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.\n* Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)\n* Have a known hypersensitivity to any of the procedural agents or study drug components\n* Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject'}, 'identificationModule': {'nctId': 'NCT03688802', 'briefTitle': 'Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oyster Point Pharma, Inc.'}, 'officialTitle': 'A Single-Center, Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)', 'orgStudyIdInfo': {'id': 'OPP-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OC-01 (varenicline) nasal spray, 1.2 mg/mL', 'description': 'OC-01 (varenicline) nasal spray, 1.2 mg/mL, one time dosing', 'interventionNames': ['Drug: OC-01 (varenicline) nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (vehicle control) nasal spray', 'description': 'Placebo (vehicle control) nasal spray, one time dosing', 'interventionNames': ['Drug: Placebo (vehicle control) nasal spray']}], 'interventions': [{'name': 'OC-01 (varenicline) nasal spray', 'type': 'DRUG', 'description': 'OC-01 (varenicline) nasal spray', 'armGroupLabels': ['OC-01 (varenicline) nasal spray, 1.2 mg/mL']}, {'name': 'Placebo (vehicle control) nasal spray', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo (vehicle control) nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oyster Point Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}