Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-28 @ 2:15 PM
Study NCT ID:
NCT01239069
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2010-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-05-19', 'releaseDate': '2017-04-14'}], 'estimatedResultsFirstSubmitDate': '2017-04-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2014-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of DE-110', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Individual Response Rate', 'timeFrame': '12 weeks'}, {'measure': 'Individual Efficacy', 'timeFrame': '12 weeks'}, {'measure': 'Individual Symptoms', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of dry eye\n* Not wear contact lenses during study\n* 18 years or older\n* Understand and provide written consent\n* Negative pregnancy test and use acceptable method of contraception\n\nExclusion Criteria:\n\n* Use of any topical ocular medication\n* Any type of ocular surgery\n* Diagnosis of on-going ocular infection and/or allergic conjunctivitis\n* Uncontrolled systemic conditions/lid abnormalities\n* Corneal transplants\n* Females who are pregnant, nursing or planning a pregnancy\n* Participation in another drug trial concurrently or within 30 days prior to study'}, 'identificationModule': {'nctId': 'NCT01239069', 'briefTitle': 'Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Inc.'}, 'officialTitle': 'A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease', 'orgStudyIdInfo': {'id': '30-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DE-110 ophthalmic suspension high dose', 'interventionNames': ['Drug: DE-110 ophthalmic suspension high dose']}, {'type': 'EXPERIMENTAL', 'label': 'DE-110 ophthalmic suspension low dose', 'interventionNames': ['Drug: DE-110 ophthalmic suspension low dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'DE-110 ophthalmic suspension high dose', 'type': 'DRUG', 'description': 'ophthalmic suspension; high dose; QID', 'armGroupLabels': ['DE-110 ophthalmic suspension high dose']}, {'name': 'DE-110 ophthalmic suspension low dose', 'type': 'DRUG', 'description': 'ophthalmic suspension; low dose; QID', 'armGroupLabels': ['DE-110 ophthalmic suspension low dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'DE-110 ophthalmic suspension vehicle;QID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Bloomfield', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.82649, 'lon': -72.73009}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'city': 'Rosewell', 'state': 'Georgia', 'country': 'United States'}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-04-14', 'type': 'RELEASE'}, {'date': '2017-05-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Santen Inc.'}}}}