Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01660620
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2012-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Betaxolol for the Prevention of Retinopathy of Prematurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015784', 'term': 'Betaxolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-02', 'studyFirstSubmitDate': '2012-08-06', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development of apnea and or bradycardia', 'timeFrame': '3 weeks', 'description': 'babies were monitored and HR/RR monitored and recorded by masked observers, periodically'}], 'secondaryOutcomes': [{'measure': 'development of ROP requiring treatment', 'timeFrame': '7 weeks', 'description': 'Type I ROP was used as a secondary outcome measure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['betaxolol/ retinopathy of prematurity'], 'conditions': ['Development of Side Effects From Betaxolol']}, 'descriptionModule': {'briefSummary': 'We hypothesize that topical betaxolol will reduce the development of severe retinopathy of prematurity.', 'detailedDescription': 'The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when ROP is most likely to arise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '32 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<1251 grms birth weight\n\nExclusion Criteria:\n\n* ocular defect'}, 'identificationModule': {'nctId': 'NCT01660620', 'briefTitle': 'Topical Betaxolol for the Prevention of Retinopathy of Prematurity', 'organization': {'class': 'OTHER', 'fullName': 'Smith-Kettlewell Eye Research Institute'}, 'officialTitle': 'Topical Betaxolol for the Prevention of Retinopathy of Prematurity', 'orgStudyIdInfo': {'id': '108298'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'betaxolol', 'description': 'betaxolol 0.25% 2 per day for 3 weeks', 'interventionNames': ['Drug: Betaxolol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'masked labeling also 2 per day administration', 'interventionNames': ['Drug: topical betaxolol']}], 'interventions': [{'name': 'Betaxolol', 'type': 'DRUG', 'armGroupLabels': ['betaxolol']}, {'name': 'topical betaxolol', 'type': 'DRUG', 'description': 'given topically', 'armGroupLabels': ['placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith-Kettlewell Eye Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ohio State University', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'University of Oklahoma', 'class': 'OTHER'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Administrator', 'investigatorFullName': 'William V Good, MD', 'investigatorAffiliation': 'Smith-Kettlewell Eye Research Institute'}}}}