Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 9:23 AM
Study NCT ID:
NCT04909450
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-16', 'mcpReleaseN': 27, 'releaseDate': '2025-08-29'}], 'estimatedResultsFirstSubmitDate': '2025-08-29'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-05-27', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy as Assessed by Complete Corneal Healing', 'timeFrame': 'Week 8 through Week 10', 'description': 'Proportion of subjects achieving complete corneal healing as assessed by the Central Reading Center'}, {'measure': 'Safety as Assessed by Adverse Event Reporting', 'timeFrame': 'Screening through Week 10', 'description': 'Incidence of ocular and systemic adverse events'}, {'measure': 'Safety as Assessed by Slit-lamp Biomicroscopy', 'timeFrame': 'Screening through Week 10', 'description': 'Change from baseline in staining using NEI scale (0 = absent to 3 = severe for 5 areas of the cornea) with Grade 0 (no staining) to maximum of Grade 15'}, {'measure': 'Safety as Assessed by Intraocular Pressure', 'timeFrame': 'Screening through Week 10', 'description': 'Change in baseline in intraocular pressure using the Goldmann tonometry'}, {'measure': 'Safety as Assessed by Dilated Fundus Examination', 'timeFrame': 'Screening through Week 10', 'description': 'Change from baseline in observed anomalies of the peripheral retina, macula, choroid, optic nerve and vitreous (cup/disc ratio)'}, {'measure': 'Safety as Assessed by Best-Corrected Distance Visual Acuity', 'timeFrame': 'Screening through Week 10', 'description': 'Change from baseline using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart'}], 'secondaryOutcomes': [{'measure': 'Efficacy as Assessed by Corneal Healing', 'timeFrame': 'Week 1 through Week 10', 'description': 'Time to corneal healing based on assessments by the Central Reading Center'}, {'measure': 'Efficacy as Assessed by Corneal Healing at Week 4', 'timeFrame': 'Week 1 through Week 4', 'description': 'Proportion of subjects achieving corneal healing at Week 4 assessed by the Central Reading Center'}, {'measure': 'Efficacy as Assessed by Corneal Healing at Week 4 and Week 8 Sustained for Two Weeks', 'timeFrame': 'Weeks 4 and 8 through Week 10', 'description': 'Proportion of subjects achieving corneal healing at Week 4 and Week sustained for 2 weeks as assessed by the investigator'}, {'measure': 'Efficacy as Assessed by Decrease in Lesion Size', 'timeFrame': 'Week 1 through Week 10', 'description': 'Time to ≥20% decrease in lesion size (maximum diameter) from baseline assessed by the Central Reading Center'}, {'measure': 'Efficacy as Assessed by Time to Corneal Healing', 'timeFrame': 'Week 1 through Week 10', 'description': 'Time to corneal healing based on assessments by the investigator'}, {'measure': 'Efficacy as Assessed by Best Corrected Distance Visual Acuity', 'timeFrame': 'Week 1 through Weeks 4 and 8', 'description': 'Proportion of subjects achieving a ≥15-letter gain in the study eye from baseline in Best Corrected Distance Visual Acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurotrophic Keratitis']}, 'referencesModule': {'references': [{'pmid': '35266655', 'type': 'DERIVED', 'citation': 'Hamrah P, Yavuz Saricay L, Ozmen MC. Cutting Edge: Topical Recombinant Nerve Growth Factor for the Treatment of Neurotrophic Keratopathy-Biologicals as a Novel Therapy for Neurotrophic Keratopathy. Cornea. 2022 Jun 1;41(6):673-679. doi: 10.1097/ICO.0000000000002974. Epub 2022 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK). Subjects with bilateral NK may enroll in the study but only one eye will be selected as the study eye (worse eye) and be treated with test article.\n* Subjects with no clinical evidence of improvement in the PED or corneal ulcer within the 2 weeks prior to study enrollment despite the use of conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops and medications that can decrease corneal sensitivity; therapeutic contact lenses \\[either silicone hydrogel or rigid gas permeable\\]) as determined by the investigator or referring physician's medical record.\n* Subjects with clinical evidence of decreased corneal sensitivity within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant in the study eye in the opinion of the investigator assessed with a cotton wisp.\n* Pinhole distance visual acuity score ≤ 75 ETDRS letters measured with a LogMAR chart (≥ 0.2 LogMAR, ≤ 20/32 Snellen or worse Snellen or ≤ 0.625 decimal fraction) in the study eye.\n* Subjects must have the ability and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n* Any active ocular infection (bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in either eye in the opinion of the investigator. Infectious epithelial keratitis including herpetic keratitis (i.e., dendritic lesions or geographic ulcers) in either eye is excluded. Subjects on oral antibiotic at the time of screening are eligible but should continue the medication for the duration of the study.\n* Previous use of Oxervate in the study eye with last administration within the past 2 months.\n* Any other ocular disease, except glaucoma, that will require topical ocular treatment in the study eye over the course of the study.\n* Use of any other topical treatments other than the study medication provided by the Sponsor and allowed by the study protocol can be administered to the study eye over the course of the study. The following are exceptions: a) Allowance for use of preservative-free antibiotic eye drops if prescribed by the investigator and b) Allowance for use of a non-preserved IOP-lowering prostaglandin topical ocular drop administered once-daily (QD) in glaucomatous eyes over the course of the study.\n\nNote: Other inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT04909450', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Claris Biotherapeutics, Inc.'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects', 'orgStudyIdInfo': {'id': 'CSB-C20-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSB-001 Investigational Treatment Arm', 'description': 'One drop CSB-001 four times daily for 8 weeks in the study eye', 'interventionNames': ['Biological: CSB-001 Ophthalmic Solution 0.1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Control Arm', 'description': 'One drop matching vehicle four times daily for 8 weeks in the study eye', 'interventionNames': ['Biological: Vehicle Control']}], 'interventions': [{'name': 'CSB-001 Ophthalmic Solution 0.1%', 'type': 'BIOLOGICAL', 'description': 'CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)', 'armGroupLabels': ['CSB-001 Investigational Treatment Arm']}, {'name': 'Vehicle Control', 'type': 'BIOLOGICAL', 'description': 'Matching vehicle control without the drug substance', 'armGroupLabels': ['Vehicle Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85331', 'city': 'Cave Creek', 'state': 'Arizona', 'country': 'United States', 'facility': 'Eye Care North', 'geoPoint': {'lat': 33.83333, 'lon': -111.95083}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Eye Institute', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90013', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Nvision Clinical Research, LLC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90041', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Foundation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Stein Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92562', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'LoBue Laser and Eye Medical Center, Inc.', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'California Eye Specialists Medical Group Inc.', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Martel Eye Medical Group', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Gordon Schanzlin New Vision Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Atlantis Eyecare', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Dept. of Ophthalmology', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Vision Institute', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Corneal Consultants of Colorado', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Bowden Eye and Associates', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'International Eye Associates, PA', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33418', 'city': 'Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute at Palm Beach Gardens', 'geoPoint': {'lat': 26.70562, 'lon': -80.03643}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'International Research Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30339', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eye Consultants of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46290', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Cornea Associates, LLC', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Price Vision Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '40517', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Eye Institute', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55436', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Cornea and Contact Lens Institute of Minnesota', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55305', 'city': 'Minnetonka', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants', 'geoPoint': {'lat': 44.9133, 'lon': -93.50329}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Tauber 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': '07650', 'city': 'Palisades Park', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Metropolitan Eye Research and Surgery Institute', 'geoPoint': {'lat': 40.84816, 'lon': -73.99764}}, {'zip': '11702', 'city': 'Babylon', 'state': 'New York', 'country': 'United States', 'facility': 'SightMD', 'geoPoint': {'lat': 40.69566, 'lon': -73.32568}}, {'zip': '12159', 'city': 'Slingerlands', 'state': 'New York', 'country': 'United States', 'facility': 'Cornea Consultants of Albany', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Eye Consultants of North Dakota', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University, Department of Ophthalmology and Visual Sciences', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Devers Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18202', 'city': 'Hazle Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hazleton Eye Specialists'}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scheie Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Eye Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Cataract & Laser Center', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'BLINK Research Center, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin; The Mitchel and Shannon Wong Eye Institute', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78212', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Stuart A. Terry, MD PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Eye Consultants', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': 'V5Z 1K1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Gregory Moloney', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K1G 5L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Precision Cornea Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5T 3A9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kensington Eye Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claris Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}