Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2026-01-25 @ 12:21 AM
Study NCT ID:
NCT00579020
Status:
TERMINATED
Last Update Posted:
2012-12-05
First Post:
2007-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D001762', 'term': 'Blepharitis'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'whyStopped': 'Management decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2012-12-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2007-12-19', 'dispFirstSubmitQcDate': '2012-12-03', 'studyFirstSubmitQcDate': '2007-12-19', 'dispFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with resolution of all corneal stromal infiltrate(s) in study eye at Test of Cure (TOC) Visit (Day 10)', 'timeFrame': 'Day 10'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with eradication of pre-therapy pathogens from the lid of the study eye at TOC Visit (Day 10)', 'timeFrame': 'Day 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cornea', 'inflammation', 'blepharitis', 'lid infection'], 'conditions': ['Corneal Infiltrates']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether Moxidex ophthalmic solution is safe and effective in treating marginal corneal infiltrates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of marginal corneal infiltrates of size equal to or less than 1.5mm in diameter, with mild, moderate or severe bulbar conjunctival injection in at least one eye.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Age related.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00579020', 'briefTitle': 'A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates', 'orgStudyIdInfo': {'id': 'C-05-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moxidex', 'description': 'Moxifloxacin/dexamethasone phosphate ophthalmic solution, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days', 'interventionNames': ['Drug: Moxifloxacin/dexamethasone phosphate ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': 'Moxifloxacin ophthalmic solution 0.5%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days', 'interventionNames': ['Drug: Moxifloxacin ophthalmic solution 0.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Dexamethasone phosphate solution, 0.1%, one drop in cul-de-sac and 4 drops on closed lids of study eye(s), four times a day, for seven days', 'interventionNames': ['Drug: Dexamethasone phosphate solution, 0.1%']}], 'interventions': [{'name': 'Moxifloxacin/dexamethasone phosphate ophthalmic solution', 'type': 'DRUG', 'otherNames': ['Moxidex'], 'armGroupLabels': ['Moxidex']}, {'name': 'Moxifloxacin ophthalmic solution 0.5%', 'type': 'DRUG', 'armGroupLabels': ['Moxifloxacin']}, {'name': 'Dexamethasone phosphate solution, 0.1%', 'type': 'DRUG', 'armGroupLabels': ['Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center at 1-888-451-3937', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}