Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-10 @ 9:41 PM
Study NCT ID:
NCT06515457
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2024-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014985', 'term': 'Xerophthalmia'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Visual Clarity', 'timeFrame': 'Baseline, Week 1, Week 2, and Week 3', 'description': 'Participants will report on their visual clarity through self-reported questionnaires. The questionnaires will evaluate changes in visual clarity from baseline.'}, {'measure': 'Reduction in Eye Dryness', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'Participants will self-report changes in eye dryness through questionnaires administered at specific intervals during the study. Parameters include the frequency and severity of dry eye symptoms.'}, {'measure': 'Reduction in Symptoms of Inflammation', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'Participants will self-report changes in symptoms of eye inflammation through questionnaires administered at specific intervals during the study. Parameters include redness, irritation, and discomfort.'}, {'measure': 'Reduction in Sensitivity to Blue Light', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'Participants will self-report changes in sensitivity to blue light through questionnaires administered at specific intervals during the study. Parameters include the degree of discomfort experienced when exposed to blue light from screens and other sources.'}], 'secondaryOutcomes': [{'measure': 'Improvement in Overall Eye Health', 'timeFrame': 'Baseline, Week 1, Week 2, and Week 3', 'description': 'Participants will report on their overall eye health through self-reported questionnaires. The questionnaires will assess changes in symptoms such as eye dryness, symptoms of inflammation, and sensitivity to blue light.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vision Health', 'Eye Empower'], 'conditions': ['Inflammation Symptoms', 'Eye Dryness', 'Eye Health']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the efficacy of BioNatureHealth's Eye Empower supplement in supporting vision and eye health. It is a virtual, single-group trial lasting 3 weeks. Participants will take three capsules of the supplement daily and complete questionnaires at Baseline, Week 1, Week 2, and Week 3 to assess visual clarity, dryness, symptoms of inflammation, and sensitivity to blue light."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female at birth, aged 40 or over\n* Self-reported concerns about at least two of the following symptoms: dry eyes, red/itchy/irritated eyes, sensitivity to blue light, blurred vision (far or near)\n* Generally healthy without uncontrolled chronic diseases\n* Willing to avoid using new eye health prescriptions, over-the-counter medications, supplements, and herbal remedies for the study duration\n* Consistent use of current eye health supplements or herbal remedies for at least 3 months prior to the study\n* Willing to maintain current diet, sleep schedule, and activity level during the study\n\nExclusion Criteria:\n\n* Pre-existing chronic conditions preventing protocol adherence, including oncological and psychiatric disorders\n* Diagnosed diabetes (Type I or II)\n* Planning to undergo any eye-related procedures during the study\n* Recent surgeries or invasive treatments within the last six months\n* History of major illness within the last three months\n* Recent use of a supplement with active ingredients in the test product\n* Severe allergic reactions requiring an EpiPen, including shellfish allergy\n* Pregnant, breastfeeding, or planning to conceive\n* Use of medications or herbal supplements that impact the blood\n* Non-consumption of animal products for religious or personal reasons\n* Unwillingness to follow the study protocol\n* Anyone with a history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT06515457', 'briefTitle': 'A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bio Nature Health'}, 'officialTitle': 'A Clinical Trial to Evaluate the Efficacy of an Oral Supplement in Supporting Vision and Eye Health', 'orgStudyIdInfo': {'id': '20425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye Empower Supplement Arm', 'description': "Participants in this arm will take three capsules of BioNatureHealth's Eye Empower supplement daily for three weeks.", 'interventionNames': ['Dietary Supplement: Eye Empower']}], 'interventions': [{'name': 'Eye Empower', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BioNatureHealth Eye Empower'], 'description': 'Participants will take three capsules of the Eye Empower supplement daily for three weeks.', 'armGroupLabels': ['Eye Empower Supplement Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bio Nature Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}