Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT06412393
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2024-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Eye Health Benefits of Black Tomato Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure Measurement (IOP)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg'}, {'measure': 'Grading of Retinal Vascular Diameter', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Grading of Retinal Vascular Diameter using a fundus camera.'}, {'measure': 'Visual Contrast Sensitivity Function', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Perform the Visual Contrast Sensitivity Test (Distance and near) under environmental illumination/dark/bright conditions.'}, {'measure': 'Negative Fusional Vergence (NFV)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Negative Fusional Vergence using a phoropter.'}, {'measure': 'Positive Fusional Vergence (PFV)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Positive Fusional Vergence using a phoropter.'}, {'measure': 'Negative Relative Accommodation (NRA)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Negative Relative Accommodation using a phoropter.'}, {'measure': 'Positive Relative Accommodation (PRA)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Positive Relative Accommodation using a phoropter.'}, {'measure': 'Accommodative Facility', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Accommodative Facility using a Flipper lens ±2.00D.'}], 'secondaryOutcomes': [{'measure': 'Questionnaire Survey - Ocular Surface Disease Index (OSDI)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.'}, {'measure': 'The change of Endothelin-1 (ET-1)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Fasting venous blood will be sampled to measure concentrations of ET-1.'}, {'measure': 'The change of Tumor necrosis factor-α (TNF-α)', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Fasting venous blood will be sampled to measure concentrations of TNF-α.'}, {'measure': 'Best-corrected visual acuity', 'timeFrame': 'Change from Baseline at 8 weeks', 'description': 'Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eye', 'High Myopia']}, 'descriptionModule': {'briefSummary': 'Verification of the efficacy of black tomato extract for eye health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 20 and capable of providing informed consent.\n* Daily usage of 3C (computer, communication, and consumer electronics) for more than 6 hours (OSDI screening - those experiencing dryness and fatigue in the eyes).\n* BMI between 22 and 35.\n* High myopia population (-5.00 to -9.00D)\n\nExclusion Criteria:\n\n* History of any eye surgery (e.g., strabismus surgery, refractive surgery).\n* Presence of systemic diseases affecting the anterior surface of the eye.\n* Long-term use of medications affecting the anterior surface of the eye.'}, 'identificationModule': {'nctId': 'NCT06412393', 'briefTitle': 'Evaluation of Eye Health Benefits of Black Tomato Extract', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Evaluation of Eye Health Benefits of Black Tomato Extract', 'orgStudyIdInfo': {'id': 'CS1-23170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo powder', 'description': 'Dietary Supplement: Placebo powder', 'interventionNames': ['Dietary Supplement: Placebo powder']}, {'type': 'EXPERIMENTAL', 'label': 'Black tomato extract powder', 'description': 'Dietary Supplement: Black tomato extract powder', 'interventionNames': ['Dietary Supplement: Black tomato extract powder']}], 'interventions': [{'name': 'Black tomato extract powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'take 2 packets per day for 8 weeks', 'armGroupLabels': ['Black tomato extract powder']}, {'name': 'Placebo powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'take 2 packets per day for 8 weeks', 'armGroupLabels': ['Placebo powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Bo-Yie Chen boychen@csmu.edu.tw', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}