Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-31 @ 2:28 PM
Study NCT ID:
NCT05848128
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-21', 'mcpReleaseN': 9, 'releaseDate': '2025-04-02'}, {'resetDate': '2025-05-28', 'mcpReleaseN': 10, 'releaseDate': '2025-05-12'}], 'estimatedResultsFirstSubmitDate': '2025-04-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye 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': 642}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-04-27', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale', 'timeFrame': 'Baseline to Day 85', 'description': 'The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior). Grade 0 was specified when no staining is present. The maximum score was 15.'}, {'measure': 'Change From Baseline in Eye Dryness Score as Measured by the VAS', 'timeFrame': 'Baseline to Day 85', 'description': 'The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes', 'Dry Eye Disease', 'Kerato Conjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of 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* Subject-reported history of dry eye disease in both eyes for at least 6 months;\n* History of use of artificial tear eye drops for dry eye symptoms;\n* Total score of ≥40 on SANDE;\n* TFBUT;\n* Corneal fluorescein staining;\n* Lissamine green conjunctival staining;\n* Schirmer's test score.\n\nExclusion Criteria:\n\n* Have participated in a previous tavilermide (MIM-D3) study;\n* Have clinically significant slit lamp findings at Visit 1;\n* Have a history of lacrimal duct obstruction within 12 months of Visit 1;\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 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 prior to Visit 1."}, 'identificationModule': {'nctId': 'NCT05848128', 'briefTitle': 'Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mimetogen Pharmaceuticals USA, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye', 'orgStudyIdInfo': {'id': 'MIM-729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5% Tavilermide ophthalmic solution', 'interventionNames': ['Drug: 5% Tavilermide ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle ophthalmic solution', 'interventionNames': ['Other: Vehicle ophthalmic solution']}], 'interventions': [{'name': '5% Tavilermide ophthalmic solution', 'type': 'DRUG', 'description': 'Twice a day topicial dosing', 'armGroupLabels': ['5% Tavilermide ophthalmic solution']}, {'name': 'Vehicle ophthalmic solution', 'type': 'OTHER', 'description': 'Twice a day topical dosing', 'armGroupLabels': ['Vehicle ophthalmic solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85003', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Eye Doctors of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92562', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'LoBue Laser and Eye Medical Center', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '34429', 'city': 'Crystal River', 'state': 'Florida', 'country': 'United States', 'facility': 'Nature Coast Clinical Research', 'geoPoint': {'lat': 28.90248, 'lon': -82.5926}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Bowden Eye & Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33773', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Shettle Eye Research', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '30339', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eye Consultants of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Price Vision Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '21078', 'city': 'Havre de Grace', 'state': 'Maryland', 'country': 'United States', 'facility': 'Seidenberg Protzko Eye Associates', 'geoPoint': {'lat': 39.54928, 'lon': -76.09162}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Vision Research Foundation', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '64133', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Silverstein Eye Centers', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Moyes Eye Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Ophthalmological Group', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27529', 'city': 'Garner', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oculus Research', 'geoPoint': {'lat': 35.71126, 'lon': -78.61417}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'James D. Branch', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44115', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Abrams Eye Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'West Bay Eye Associates', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Toyos Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Laser Vision & Surgical Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78738', 'city': 'Lakeway', 'state': 'Texas', 'country': 'United States', 'facility': 'Lake Travis Eye & Laser Center/Revolution Research', 'geoPoint': {'lat': 30.36377, 'lon': -97.97959}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'PNV Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The Eye Institute of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mimetogen Pharmaceuticals USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}