Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-03 @ 11:04 PM
Study NCT ID:
NCT04380857
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2020-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing Dextenza Insert After SMILE Procedure
Sponsor:
Organization:
Raw JSON
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'Kathleen Jee, MD', 'organization': 'Cleveland Eye Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 90 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Dexamethasone Ophthalmic Insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg\n\nDexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Topical Prednisolone Acetate Ophthalmic Drops', 'description': 'Topical prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Intraocular pressure elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Ophthalmic Insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg\n\nDexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert'}, {'id': 'OG001', 'title': 'Topical Prednisolone Acetate Ophthalmic Drops', 'description': 'Topical prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.95', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.41', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90', 'description': 'post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)', 'unitOfMeasure': 'Score on a scale from 0-10', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All subjects were seen through week 1; three were lost to follow up thereafter.'}, {'type': 'SECONDARY', 'title': 'Number of Lines Lost From Best Corrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Ophthalmic Insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg\n\nDexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert'}, {'id': 'OG001', 'title': 'Topical Prednisolone Acetate Ophthalmic Drops', 'description': 'Topical prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Day 90', 'description': 'After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All subjects were seen through week 1; three were lost to follow up thereafter.'}, {'type': 'SECONDARY', 'title': 'Loss of Lines in Uncorrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Ophthalmic Insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg\n\nDexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert'}, {'id': 'OG001', 'title': 'Topical Prednisolone Acetate Ophthalmic Drops', 'description': 'Topical prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.'}], 'classes': [{'title': '1 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.0114', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.183', 'groupId': 'OG001'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.014', 'spread': '0.181', 'groupId': 'OG000'}, {'value': '-0.026', 'spread': '0.160', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.071', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-0.068', 'spread': '0.156', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7, Day 30 and Day 90', 'description': 'All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All subjects were seen through week 1; three were lost to follow up thereafter.'}, {'type': 'SECONDARY', 'title': 'Post op Pain Management Per Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Ophthalmic Insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg\n\nDexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert'}, {'id': 'OG001', 'title': 'Topical Prednisolone Acetate Ophthalmic Drops', 'description': 'Topical prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 0 to Day 90', 'description': 'Count of participants requiring pain management from Day 0 to Day 90.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Patient Preference Between Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Ophthalmic Insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg\n\nDexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert'}, {'id': 'OG001', 'title': 'Topical Prednisolone Acetate Ophthalmic Drops', 'description': 'Topical prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.'}, {'id': 'OG002', 'title': 'No Preference', 'description': 'No Preference'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7, Day 30 and Day 90', 'description': 'As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects were seen through week 1; three were lost to follow up thereafter.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexamethasone Ophthalmic Insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg\n\nDexamethasone ophthalmic insert 0.4 mg: intracanalicular dexamethasone insert'}, {'id': 'FG001', 'title': 'Topical Prednisolone Acetate Ophthalmic Drops', 'description': 'Topical prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '20'}, {'groupId': 'FG001', 'numUnits': '20', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '17', 'numSubjects': '17'}, {'groupId': 'FG001', 'numUnits': '17', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'recruitmentDetails': 'This prospective, randomized, fellow-eye controlled study was conducted at a single site (Clear Choice Custom LASIK Center) in 20 patients (40 eyes) with three surgeons between June 2020 and June 2021 and was performed according to guidelines established by the Declaration of Helsinki.', 'preAssignmentDetails': 'Twenty-three patients were enrolled in the study. One patient failed screening and was not randomized. Two additional patients were randomized, but the Dextenza insert could not be successfully placed in the assigned eye at the time of surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled Patients', 'description': 'Enrolled patients who underwent SMILE surgery in both eyes with investigational treatment in one eye and standard of care treatment in the fellow eye.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-12', 'size': 4894288, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-07T09:31', 'hasProtocol': True}, {'date': '2022-11-22', 'size': 15359, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-10T09:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First eye randomized for either topical prednisolone acetate (control eye) or lower eyelid canaliculus Dextenza insertion (study eye) and the contralateral eye receiving opposite treatment in the OR following SMILE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2020-05-05', 'resultsFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-24', 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Pain', 'timeFrame': 'Change is being assessed at Baseline, Day 1, Day 7, Day 30 and Day 90', 'description': 'post-op pain as measured as scores on an Ocular Pain Assessment Scale from 0-10 ("0" being no pain and "10" being the worst pain you could imagine)'}], 'secondaryOutcomes': [{'measure': 'Number of Lines Lost From Best Corrected Visual Acuity', 'timeFrame': 'Baseline through Day 90', 'description': 'After manifest refraction all units assessed for best corrected distance visual acuity using ETDRS. Number of lines seen was then converted to LogMar score (on a scale of -0.30 to 1.00 where smaller numbers indicate better vision and larger numbers indicate worse vision) to measure changes in Best Corrected Distance Visual Acuity between Baseline and Day 90'}, {'measure': 'Loss of Lines in Uncorrected Visual Acuity', 'timeFrame': 'Baseline to Day 7, Day 30 and Day 90', 'description': 'All units assessed for uncorrected visual acuity using ETDRS. Number of lines seen was then converted to LogMar to measure changes in uncorrected visual acuity between Baseline and Day 90.'}, {'measure': 'Post op Pain Management Per Eye', 'timeFrame': 'Day 0 to Day 90', 'description': 'Count of participants requiring pain management from Day 0 to Day 90.'}, {'measure': 'Patient Preference Between Groups', 'timeFrame': 'Day 7, Day 30 and Day 90', 'description': 'As reported by patients choosing one of five options; Strongly preferred insert, preferred insert, no preference, preferred standard drop regimen, strongly preferred standard drop regimen.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Procedural Infection']}, 'descriptionModule': {'briefSummary': 'This three-month prospective, open-label, single-center, randomized investigator initiated clinical study seeks to investigate the efficacy of DEXTENZA when placed in the lower canaliculus (study eye) compared to topical corticosteroids (control eye) following bilateral SMILE surgery. In addition, the study will evaluate physician assessment of ease of DEXTENZA insertion', 'detailedDescription': "4.1 Study Population The study aims to enroll 20 patients undergoing bilateral SMILE.\n\n4.1.1 Inclusion Criteria\n\nA patient's study eye must meet the following criteria to be eligible for inclusion in the study:\n\n* Age 18 years and older\n* Scheduled for bilateral SMILE surgery\n* Willing and able to comply with clinic visits and study related procedures\n* Willing and able to sign the informed consent form\n\n4.1.2 Exclusion Criteria\n\nA patient who meets any of the following criteria will be excluded from the study:\n\n* Patients under the age of 18.\n* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)\n* Active infectious systemic disease\n* Active infectious ocular or extraocular disease\n* Obstructed nasolacrimal duct in the study eye(s)\n* Hypersensitivity to dexamethasone\n* Patients being treated with immunomodulating agents in the study eye(s)\n* Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Scheduled for bilateral SMILE surgery\n* Willing and able to comply with clinic visits and study related procedures\n* Willing and able to sign the informed consent form\n\nExclusion Criteria:\n\n* Patients under the age of 18.\n* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)\n* Active infectious systemic disease\n* Active infectious ocular or extraocular disease\n* Obstructed nasolacrimal duct in the study eye(s)\n* Hypersensitivity to dexamethasone\n* Patients being treated with immunomodulating agents in the study eye(s)\n* Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT04380857', 'briefTitle': 'Assessing Dextenza Insert After SMILE Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Cleveland Eye Clinic'}, 'officialTitle': 'Assessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Comparison to Topical Prednisolone Acetate Following Bilateral Small Incision Lenticule Extraction (SMILE)', 'orgStudyIdInfo': {'id': 'WW-2020-DexSMILE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone ophthalmic insert 0.4 mg', 'description': 'Dexamethasone ophthalmic insert 0.4 mg', 'interventionNames': ['Drug: Dexamethasone ophthalmic insert 0.4 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical prednisolone acetate ophthalmic drops', 'description': 'topical prednisolone acetate ophthalmic drops', 'interventionNames': ['Drug: Topical Prednisolone Acetate Ophthalmic Drops']}], 'interventions': [{'name': 'Dexamethasone ophthalmic insert 0.4 mg', 'type': 'DRUG', 'otherNames': ['Dextenza'], 'description': 'intracanalicular dexamethasone insert', 'armGroupLabels': ['Dexamethasone ophthalmic insert 0.4 mg']}, {'name': 'Topical Prednisolone Acetate Ophthalmic Drops', 'type': 'DRUG', 'otherNames': ['Prednisolone Acetate'], 'description': 'Topical Prednisolone acetate ophthalmic drops per standard of care:\n\nEvery two hours on day of procedure, then four times a day for the first week, then two times a day for the second week, then discontinue', 'armGroupLabels': ['Topical prednisolone acetate ophthalmic drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44141', 'city': 'Brecksville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Eye Clinic', 'geoPoint': {'lat': 41.31978, 'lon': -81.62679}}], 'overallOfficials': [{'name': 'William Wiley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Eye Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William Wiley, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William Wiley, MD', 'investigatorAffiliation': 'Cleveland Eye Clinic'}}}}