Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-28 @ 7:26 PM
Study NCT ID:
NCT06209203
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2024-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2024-01-06', 'studyFirstSubmitQcDate': '2024-01-06', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Corneal staining', 'timeFrame': 'seven days', 'description': 'The percentage of corneal staining negative at 48h, 72h, 120h and 168h after surgery'}], 'primaryOutcomes': [{'measure': 'healing time', 'timeFrame': 'seven days', 'description': 'Corneal epithelial healing time'}], 'secondaryOutcomes': [{'measure': 'number of healing', 'timeFrame': 'seven days', 'description': 'The percentage of corneal healing at 24h, 48h, 72h, 120h and 168h after operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Epithelium Defect']}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.', 'detailedDescription': 'Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7.\n\nStatistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of 18-40 years old, regardless of gender;\n2. Plan TPRK for myopia and/or myopic astigmatism, meet the indications for TPRK, and set the ablation diameter of the optical zone at 6.0-6.5 mm;\n3. Schirmer test I ≥10mm/5min;\n\nExclusion Criteria:\n\n1. prior corneal refractive surgery or keratoplasty;\n2. Contraindications to TPRK surgery, including severe ocular surface disease that may affect the corneal epithelium, active ocular inflammation, moderate to severe dry eye, keratoconus or other types of corneal ectasia, thin corneas, severe lesions of ocular appendages (such as eyelid defects, deformations, etc.), glaucoma, cataract that affects vision, History of systemic immune diseases (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.);\n3. incomplete eyelid closure;\n4. corneal degeneration, corneal stroma or endothelial damage or malnutrition;'}, 'identificationModule': {'nctId': 'NCT06209203', 'acronym': 'TPRK', 'briefTitle': 'A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops in Patients with Corneal Epithelial Defects After TPRK', 'orgStudyIdInfo': {'id': 'ZKO-SFT-202112-TPRK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lowe-dose ZKY001 eye drops', 'description': 'The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6', 'interventionNames': ['Drug: lowe-dose ZKY001 eye drops']}, {'type': 'EXPERIMENTAL', 'label': 'Medium-dose ZKY001 eye drops', 'description': 'The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6', 'interventionNames': ['Drug: Medium-dose ZKY001 eye drops']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'lowe-dose ZKY001 eye drops', 'type': 'DRUG', 'otherNames': ['ZKY001'], 'description': 'eye drops', 'armGroupLabels': ['lowe-dose ZKY001 eye drops']}, {'name': 'Medium-dose ZKY001 eye drops', 'type': 'DRUG', 'otherNames': ['ZKY001'], 'description': 'eye drops', 'armGroupLabels': ['Medium-dose ZKY001 eye drops']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Simulated eye drops'], 'description': 'eye drops', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Eye & ENT Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xingtao Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye & ENT Hospital of Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}