Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-29 @ 12:55 AM
Study NCT ID:
NCT01714960
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2012-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Day 1 up to day 23'}], 'secondaryOutcomes': [{'measure': 'Area under the curve (AUC)', 'timeFrame': 'Day 1 to day 17'}, {'measure': 'Maximal plasma concentration (Cmax)', 'timeFrame': 'Day 1 to day 17'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers and Glaucoma Patients']}, 'descriptionModule': {'briefSummary': '* To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2).\n* To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor stage 1:\n\n\\- Healthy volunteers\n\nFor stage 2:\n\n\\- Glaucoma patients\n\nExclusion Criteria:\n\nFor stage 2:\n\n\\- Any relevant eye disease other than glaucoma'}, 'identificationModule': {'nctId': 'NCT01714960', 'briefTitle': 'Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz Pharmaceuticals GmbH'}, 'officialTitle': 'Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients', 'orgStudyIdInfo': {'id': 'MRZ99030_1001_1'}, 'secondaryIdInfos': [{'id': '2012-002664-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers low dose', 'description': 'MRZ-99030 eye drops (5mg/mL), 1-3 drops three times per day, duration: 16 days.', 'interventionNames': ['Drug: MRZ-99030 eye drops 5mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers high dose', 'description': 'MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.', 'interventionNames': ['Drug: MRZ-99030 eye drops 20mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Glaucoma patients', 'description': 'MRZ-99030 eye drops (20mg/mL), 1-3 drops three times per day, duration: 16 days.', 'interventionNames': ['Drug: MRZ-99030 eye drops 20mg/mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo eye drops, 1-3 drops three times per day, duration: 16 days.', 'interventionNames': ['Drug: Placebo to MRZ-99030 eye drops']}], 'interventions': [{'name': 'MRZ-99030 eye drops 5mg/mL', 'type': 'DRUG', 'armGroupLabels': ['Healthy volunteers low dose']}, {'name': 'MRZ-99030 eye drops 20mg/mL', 'type': 'DRUG', 'armGroupLabels': ['Glaucoma patients', 'Healthy volunteers high dose']}, {'name': 'Placebo to MRZ-99030 eye drops', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Parexel International GmbH, Early Phase Clinical Unit', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz Pharmaceuticals GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz Pharmaceuticals GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}