Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 12:57 PM
Study NCT ID:
NCT04234932
Status:
UNKNOWN
Last Update Posted:
2020-04-14
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-12', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripapillary capillary perfusion density', 'timeFrame': '90 minutes', 'description': 'Mean change in peripapillary capillary perfusion as assessed using optical coherence tomography angiography'}], 'secondaryOutcomes': [{'measure': 'Macular capillary perfusion density', 'timeFrame': '90 minutes', 'description': 'Mean change in macular capillary perfusion as assessed using optical coherence tomography angiography'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle']}, 'descriptionModule': {'briefSummary': 'Investigate changes in optical coherence tomography angiography of the optic nerve and macula following topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal ocular health\n\nExclusion Criteria:\n\n* Females who are or may be pregnant or who are nursing\n* Uncontrolled hypertension\n* Allergy to netarsudil or latanoprost'}, 'identificationModule': {'nctId': 'NCT04234932', 'briefTitle': 'Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation', 'organization': {'class': 'OTHER', 'fullName': 'University of the Incarnate Word'}, 'officialTitle': 'Short-term Effect of Rho-kinase Inhibitor on Retinal Circulation', 'orgStudyIdInfo': {'id': '19-12-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Netarsudil alone', 'description': 'Topical application of netarsudil 0.02%', 'interventionNames': ['Drug: Netarsudil Ophthalmic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Netarsudil plus latanoprost', 'description': 'Topical application of netarsudil 0.02% with latanoprost 0.005%', 'interventionNames': ['Drug: Netarsudil Ophthalmic']}], 'interventions': [{'name': 'Netarsudil Ophthalmic', 'type': 'DRUG', 'otherNames': ['Latanoprost Ophthalmic'], 'description': 'Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)', 'armGroupLabels': ['Netarsudil alone', 'Netarsudil plus latanoprost']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana C Hagendorf, PhD', 'role': 'CONTACT', 'email': 'wandless@uiwtx.edu', 'phone': '210-805-3036'}], 'facility': 'University of the Incarnate Word', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Mary Jo Bilicek', 'role': 'CONTACT', 'email': 'bilicek@uiwtx.edu', 'phone': '210-805-3565'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Incarnate Word', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Trevino, OD, FAAO', 'investigatorAffiliation': 'University of the Incarnate Word'}}}}