Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT06188260
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2023-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index (OSDI)', 'timeFrame': 'Change in OSDI score at 2-week visit', 'description': 'Change in OSDI score at 2-week visit'}], 'secondaryOutcomes': [{'measure': 'Non invasive tear break-up time (NITBUT)', 'timeFrame': 'NITBUT at 2-week and 3-month visits', 'description': 'NITBUT at 2-week and 3-month visits'}, {'measure': 'Meibography', 'timeFrame': 'Meibography at 2-week and 3-month visits', 'description': 'Meibography at 2-week and 3-month visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'referencesModule': {'references': [{'pmid': '40343954', 'type': 'DERIVED', 'citation': 'Liao X, Guo B, Bian J, Li PH, Tse JSH, Ngo W, Zhou L, Lam T. Efficacy of a new nanoemulsion artificial tear in dry eye disease management: Study protocol for a prospective cohort study. PLoS One. 2025 May 9;20(5):e0323523. doi: 10.1371/journal.pone.0323523. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study to compare subjective changes in symptoms using the Ocular Surface Disease Index (OSDI) questionnaire, following the recommended dosage of the new nanoemulsion eye drops (Systane Complete)in mild to moderate dry eye patients, and to investigate objective ocular surface changes using modern clinical instruments during the study period.', 'detailedDescription': 'This study, lasting for 3 months in total, is to investigate the changes in both subjective reports (OSDI score) and objective measurements (Non-invasive Tear Break Time (NITBUT) and other clinical signs such as corneal staining) after the use of this nanoemulsion eye drops (Systane Complete). Subjects are required to use the eyedrop qid for 3 months, and come back for follow-up at 2-week and 3-month visits. Other secondary measurements such as Meibography and lipid layer thickness, will also be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 20-50 years old\n2. Best corrected distance visual acuity ≥ 6/9\n3. Mild to moderate OSDI score 13-32\n4. Any one of the objective test positive (NITBUT/Corneal fluorescein staining/Tear osmolarity)\n\nExclusion Criteria:\n\n1. Any active ocular infections\n2. Inflammations or anomalies in the eyelid\n3. Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months that are known to affect tear profile.\n4. Pregnancy and breastfeeding\n5. Contact lens wearers are required to stop contact lenses wear for at least 1 week before the evaluation.\n6. Subjects who are using artificial tears or other eyedrops will be excluded.\n7. Subjects who are taking systemic drugs that may cause dry eye, e.g., Antidepressants/antipsychotics, Systemic corticosteroids.'}, 'identificationModule': {'nctId': 'NCT06188260', 'briefTitle': 'Efficacy of a New Nanoemulsion Artificial Tear Targeting Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Efficacy of a New Nanoemulsion Artificial Tear in Dry Eye Disease Management', 'orgStudyIdInfo': {'id': '20230209004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry eye participants', 'description': 'Participants aged 20 years or above, with OSDI score between 12-32, and with either of the following positive signs: 1) corneal staining; 2) NITBUT\\<10s; 3) osmolarity \\>=308, or difference \\>8', 'interventionNames': ['Drug: Systane COMPLETE Lubricant Eye Drops']}], 'interventions': [{'name': 'Systane COMPLETE Lubricant Eye Drops', 'type': 'DRUG', 'otherNames': ['Alcon limited'], 'description': 'Active Ingredients: Propylene Glycol 0.6% Purpose: Lubricant', 'armGroupLabels': ['Dry eye participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '999077', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Thomas LAM', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Thomas LAM, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnique University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'LAM Chuen Thomas, FAAO, PhD', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}