Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-09 @ 12:01 AM
Study NCT ID:
NCT02139033
Status:
COMPLETED
Last Update Posted:
2014-06-11
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-10', 'studyFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear Film Break-Up Time', 'timeFrame': 'Day 15'}, {'measure': 'Ocular surface damage as measured by fluorescein staining', 'timeFrame': 'Day 15'}]}, 'conditionsModule': {'keywords': ['Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca'], 'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent;\n* Have a reported history of dry eye;\n* Have a history of use or desire to use eye drops;\n\nExclusion Criteria:\n\n* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;\n* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;\n* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;\n* Have used Restasis® within 30 days of Visit 1;\n* Be a woman who is pregnant, nursing or planning a pregnancy;\n* Be unwilling to submit a urine pregnancy test if of childbearing potential;\n* Have a known allergy and/or sensitivity to the test article or its components;\n* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;\n* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1."}, 'identificationModule': {'nctId': 'NCT02139033', 'briefTitle': 'A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ocusoft, Inc.'}, 'officialTitle': 'A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With Dry Eye', 'orgStudyIdInfo': {'id': '13-110-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Retain 1-2 drops, bilaterally, BID', 'interventionNames': ['Drug: Retaine™']}], 'interventions': [{'name': 'Retaine™', 'type': 'DRUG', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ocusoft, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}