Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-26 @ 6:04 PM
Study NCT ID:
NCT06901895
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2025-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Effect of Hyaluronic Acid and Lipid Coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Schirmer test', 'timeFrame': '12 Months', 'description': "The Schirmer's test, also known as the Schirmer tear test, is a medical test used to assess tear production, particularly when a person experiences dry eyes or excessive tearing, by measuring how much a filter paper strip gets wet by tears in the lower eyelid"}, {'measure': 'Tear Break up Test', 'timeFrame': '12 months', 'description': 'The Tear Breakup Time (TBUT) test, also known as the Tear Film Breakup Time (TFBUT) test, assesses tear film stability by measuring the time it takes for dry spots to appear on the cornea after a blink, indicating potential dry eye'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'In this study we compare the curative effect of two lubricants Hylorunic acid and visol gel on dry eyes after phacoemulsification in diabetic patients. We check the tear film before operation and check post operate after 2nd week and 4th week of surgery. Its a hospital based study .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have acute dry eye condition before phacoemulsification cataract surgery.\n\nExclusion Criteria:\n\n* Patients who have chronic dry eye condition before phacoemulsification cataract surgery.'}, 'identificationModule': {'nctId': 'NCT06901895', 'briefTitle': 'Comparing Effect of Hyaluronic Acid and Lipid Coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparing Effect of Hyaluronic Acid and Lipid Coated Carbomer Gel on Dry Eyes After Phacoemulsification in Diabetic Patients', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall23/779'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hylorunic acid', 'interventionNames': ['Combination Product: Hylorunic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lipid coated carbomer gel', 'interventionNames': ['Diagnostic Test: Lipid coated carbomer gel']}], 'interventions': [{'name': 'Hylorunic acid', 'type': 'COMBINATION_PRODUCT', 'description': 'Hylorunic acid (hylo) eye drop is prescribed and check the curative effect after phacoemulsification after 2nd and 4th week.', 'armGroupLabels': ['Hylorunic acid']}, {'name': 'Lipid coated carbomer gel', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lipid coated carbomer gel (visole)is prescribed and check yhe curative effect after phacoemulsification in diabetic patients post operatively in 2nd and 4th week.', 'armGroupLabels': ['Lipid coated carbomer gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03155419544', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Shaheen welfare hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}