Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 6:41 AM
Study NCT ID:
NCT00803803
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2008-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose, Effects and Characteristics of Pilocarpine
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1978-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '1979-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-20', 'studyFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2008-12-05', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1979-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': '25 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pilocarpine', 'POAG', 'IOP', 'Concentration', 'Frequency', 'Primary open-angle glaucoma', 'Primary open-angle glaucoma suspect'], 'conditions': ['Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this investigation, in which pilocarpine was given in repeated doses, was to evaluate: Part I - the effects of different concentrations of pilocarpine hydrochloride on intraocular pressure. Part II -the effects on intraocular pressure of glaucomatous patients to pilocarpine 2% when given once, twice and four daily. In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.', 'detailedDescription': 'In addition, we studied various attributes of the eye which may serve as indicators of responsiveness of individual patients to pilocarpine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open-angle glaucoma\n* Primary open-angle glaucoma suspect'}, 'identificationModule': {'nctId': 'NCT00803803', 'briefTitle': 'Dose, Effects and Characteristics of Pilocarpine', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'Dose, Effects and Characteristics of Pilocarpine', 'orgStudyIdInfo': {'id': '08-914E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilocarpine Concentration', 'description': 'Varying concentration 0.5 to 8% - 22 patients were examined regarding: visual acuity, iris color, pupil size, chamber angle, C/D ratio, visual field (VF), coefficient of aqueous outflow and Goldmann tonometry. After a one month washout period, pilocarpine was used 4 times daily, in concentrations from 0.5 to 8%. The amount of IOP change was compared with various clinical findings', 'interventionNames': ['Drug: Pilocarpine Concentration']}, {'type': 'EXPERIMENTAL', 'label': 'Pilocarpine Frequency', 'description': 'Varying frequency, once to four times daily - 15 patients were included in a crossover study: IOP was checked daily for 3 days and for 9 hours on fourth day. Pilocarpine was started on day 5 once daily OD and BID OS; on day 9 once daily OD and QID OS; on day 12 QID OD and once daily OS; on day 16 once daily OD and QID OS; and on day 19 QID OD and once daily OS. No medications were used on days 23-25. IOP was measured on days 4, 8, 11, 15, 18, 22 and 25.', 'interventionNames': ['Drug: Pilocarpine Frequency']}], 'interventions': [{'name': 'Pilocarpine Concentration', 'type': 'DRUG', 'description': 'Varying concentration 0.5 to 8%', 'armGroupLabels': ['Pilocarpine Concentration']}, {'name': 'Pilocarpine Frequency', 'type': 'DRUG', 'description': '1 to 4 times daily', 'armGroupLabels': ['Pilocarpine Frequency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Glaucoma Service', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'George L Spaeth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Glaucoma Service'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Surgeon', 'investigatorFullName': 'Marlene Moster, MD', 'investigatorAffiliation': 'Wills Eye'}}}}