Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-03-03 @ 4:49 PM
Study NCT ID:
NCT02665234
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'dispFirstSubmitDate': '2019-08-13', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2016-01-20', 'dispFirstSubmitQcDate': '2019-08-13', 'studyFirstSubmitQcDate': '2016-01-22', 'dispFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Corneal Fluorescein Staining Using The Ora Calibra Scale', 'timeFrame': 'Day 57', 'description': 'An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)'}, {'measure': 'Ocular Discomfort Using The Ora Calibra Scale', 'timeFrame': 'Day 57', 'description': 'A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period'}], 'secondaryOutcomes': [{'measure': 'Total Corneal Fluorescein Staining Using The Ora Calibra Scale', 'timeFrame': 'Day 15', 'description': 'An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)'}, {'measure': 'Ocular Surface Disease Index', 'timeFrame': 'Day 57'}, {'measure': 'Ocular Dryness Using The Ora Calibra Scale', 'timeFrame': '8 weeks', 'description': 'A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry Eye'], 'conditions': ['Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.'}, '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* Provided written informed consent.\n* Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye\n\nExclusion Criteria:\n\n* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1.\n* Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months.\n* Have any planned ocular and/or lid surgeries over the study period.\n* Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit .\n* Have an uncontrolled systemic disease.\n* Be a woman who is pregnant, nursing or planning a pregnancy.\n* Be a woman of childbearing potential who is not using an acceptable means of birth control\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 45 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits"}, 'identificationModule': {'nctId': 'NCT02665234', 'briefTitle': 'A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mimetogen Pharmaceuticals USA, Inc.'}, 'officialTitle': 'A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease', 'orgStudyIdInfo': {'id': 'MIM-726'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tavilermide Ophthalmic Solution', 'description': '1% Tavilermide Ophthalmic Solution', 'interventionNames': ['Drug: 1% Tavilermide Ophthalmic Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Ophthalmic Solution', 'description': 'Placebo Ophthalmic Solution', 'interventionNames': ['Drug: Placebo Ophthalmic Solution']}], 'interventions': [{'name': '1% Tavilermide Ophthalmic Solution', 'type': 'DRUG', 'description': '1% Tavilermide BID Dosing', 'armGroupLabels': ['Tavilermide Ophthalmic Solution']}, {'name': 'Placebo Ophthalmic Solution', 'type': 'DRUG', 'description': 'Vehicle Ophthalmic Solution', 'armGroupLabels': ['Vehicle Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'MIM-726 Investigational Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}], 'overallOfficials': [{'name': 'Garth Cumberlidge, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mimetogen Pharmaceuticals USA, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mimetogen Pharmaceuticals USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}