Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-30 @ 12:00 PM
Study NCT ID:
NCT00901693
Status:
TERMINATED
Last Update Posted:
2014-05-22
First Post:
2009-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D015817', 'term': 'Eye Infections'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, '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': 452}}, 'statusModule': {'whyStopped': 'Internal business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'dispFirstSubmitDate': '2014-04-17', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2009-05-08', 'dispFirstSubmitQcDate': '2014-05-07', 'studyFirstSubmitQcDate': '2009-05-13', 'dispFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained microbiological success at Day 5 or Day 7', 'timeFrame': 'Up to Day 18'}], 'secondaryOutcomes': [{'measure': 'Time to sustained microbiological success', 'timeFrame': 'Up to Day 18'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pink eye', 'eye infection', 'conjunctivitis'], 'conditions': ['Adenoviral Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.\n* Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.\n* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).\n* Must agree to comply with the visit schedule and other requirements of the study.\n* Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Sub-epithelial infiltrates at the Day 1 visit in either eye.\n* Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.\n* Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.\n* Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.\n* Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.\n* Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.\n* History of active uveitis or iritis in either eye.\n* History of corneal transplant in either eye.\n* Presence of nasolacrimal duct obstruction at Day 1.\n* Use of specified prohibited medications.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00901693', 'briefTitle': 'An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-07-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL-46383A', 'description': 'AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days', 'interventionNames': ['Drug: AL-46383A Ophthalmic Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days', 'interventionNames': ['Drug: AL-46383A Ophthalmic Solution Vehicle']}], 'interventions': [{'name': 'AL-46383A Ophthalmic Solution', 'type': 'DRUG', 'armGroupLabels': ['AL-46383A']}, {'name': 'AL-46383A Ophthalmic Solution Vehicle', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sally Scheib', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}