Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 10:24 AM
Study NCT ID:
NCT06913556
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Effect of Hylorunic 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': '2025-03-29', 'studyFirstSubmitDate': '2025-03-29', 'studyFirstSubmitQcDate': '2025-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Tear Break-Up Time (TBUT) test', 'timeFrame': '12 Months', 'description': 'The Tear Break-Up Time (TBUT) test measures how long the tear film on the eye surface remains intact before it breaks up, with a normal TBUT typically being 10 seconds or more. A shorter TBUT suggests tear film instability and potential dry eye issues.'}, {'measure': 'Schirmer test', 'timeFrame': '12 Months', 'description': 'In a Schirmer test, a score of greater than 10 mm of moistened area on the filter paper after 5 minutes is considered normal, while less than 10 mm suggests dry eyes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'In this research checked the curative effect of two different artificial tears on dry eyes after phacoemulsification was checked. In research, the randomized control trial methodology is used'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 50-70\n* Both gender male /female\n\nExclusion Criteria:\n\n* Patients who have acute dry eye condition before phacoemulsification cataract surgery.'}, 'identificationModule': {'nctId': 'NCT06913556', 'briefTitle': 'Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparing Effect of Hylorunic Acid and Lipid-coated Carbomer Gel on Dry Eyes After Phacoemulsification in Diabetic Patients', 'orgStudyIdInfo': {'id': 'MSRSW/Batch-Fall23/807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preoperative dry eyes', 'interventionNames': ['Diagnostic Test: Preoperative dry eyes']}, {'type': 'EXPERIMENTAL', 'label': 'lipid coated carbomer gel eye drops', 'interventionNames': ['Combination Product: Lipid coated carbomer gel eye drops']}], 'interventions': [{'name': 'Preoperative dry eyes', 'type': 'DIAGNOSTIC_TEST', 'description': 'In group 1 we access preoperative dry eyes condition and postoperatively we access the condition in 2nd and 4th week with the use of Hylorunic acid lubricant.', 'armGroupLabels': ['preoperative dry eyes']}, {'name': 'Lipid coated carbomer gel eye drops', 'type': 'COMBINATION_PRODUCT', 'description': 'In group 2 we prescribe the lipid coated carbomer gel eye drops and access dry eyes condition preoperative and postoperative on 2nd and 4th week and check the curative effect of drop.', 'armGroupLabels': ['lipid coated carbomer gel eye drops']}]}, 'contactsLocationsModule': {'locations': [{'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'}}}}