Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-05 @ 5:37 PM
Study NCT ID:
NCT06174935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Atropine for Symptomatic Vitreous Floaters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000726608', 'term': 'vitreous floaters'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom improvement assessed by questionnaire', 'timeFrame': 'Up to 2 months', 'description': 'NEI VFQ-25 = National Eye Institute Visual Function Questionnaire'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitreous Floaters']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to identify a potential pharmacologic option by assessing whether 0.01% atropine may be effective for treating bothersome floaters as measured by scores on a modified NEI VFQ-25.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients within Prism Vision Group with ICD diagnosis of acute posterior vitreous detachment and none of the ocular comorbidities listed as exclusion criteria will be screened as potential study participants.\n\nExclusion Criteria:\n\n* Patients with vitreous hemorrhage, other significant media opacity or vitreoretinal pathology, or history of pars plana vitrectomy will be excluded.'}, 'identificationModule': {'nctId': 'NCT06174935', 'briefTitle': 'Low Dose Atropine for Symptomatic Vitreous Floaters', 'organization': {'class': 'OTHER', 'fullName': 'Prism Vision Group'}, 'officialTitle': 'Low Dose Atropine For Symptomatic Vitreous Floaters', 'orgStudyIdInfo': {'id': '1362664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atropine 0.01%', 'description': 'Patients will apply 1 drop daily of atropine 0.01%', 'interventionNames': ['Drug: 0.01% atropine ophthalmic drop']}], 'interventions': [{'name': '0.01% atropine ophthalmic drop', 'type': 'DRUG', 'description': '0.01% atropine ophthalmic drop will be applied daily to the affected eye', 'armGroupLabels': ['Atropine 0.01%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20190', 'city': 'Reston', 'state': 'Virginia', 'country': 'United States', 'contacts': [{'name': 'Jeanette Du, MD', 'role': 'CONTACT', 'email': 'jdu@rgw.com', 'phone': '844-749-3627'}, {'name': 'Jeanette Du, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohsin Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Retina Group of Washington', 'geoPoint': {'lat': 38.96872, 'lon': -77.3411}}], 'centralContacts': [{'name': 'Jeanette Du, MD', 'role': 'CONTACT', 'email': 'JDu@rgw.com', 'phone': '844-749-3627'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeanette Du', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Jeanette Du', 'investigatorAffiliation': 'Prism Vision Group'}}}}