Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-01 @ 1:09 PM
Study NCT ID:
NCT01562795
Status:
COMPLETED
Last Update Posted:
2014-01-03
First Post:
2012-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D005469', 'term': 'Fluorometholone'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2012-03-23', 'lastUpdatePostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tear osmolarity', 'timeFrame': 'Day 0, Day 14'}], 'secondaryOutcomes': [{'measure': 'corneal staining', 'timeFrame': '0 day,7th day and 14th day after treatment'}, {'measure': 'Schirmer test(without anaesthesia)', 'timeFrame': '0 day,7th day,14th day after treatment'}, {'measure': 'tear film breakup time(TBUT)', 'timeFrame': '0 day,7th day and 14th day after treatment'}, {'measure': 'meibomian gland function', 'timeFrame': '0 day,7th day and 14th day after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Moderate to Severe Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to severe dry eye syndrome\n* tear film breakup time \\>0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min\n* corneal staining≥3 scores\n\nExclusion Criteria:\n\n* allergic to any composition of the drugs under experiment\n* previous use of anti-inflammatory drugs or immunosuppressive agent\n* viral,bacterial or fungal infection of the eye\n* eyelid anomaly\n* glaucoma or high IOP\n* significant meibomian gland dysfunction'}, 'identificationModule': {'nctId': 'NCT01562795', 'briefTitle': 'Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease', 'orgStudyIdInfo': {'id': 'Xzhou'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'interventionNames': ['Drug: nonsteroid anti-inflammatory drops']}, {'type': 'EXPERIMENTAL', 'label': 'group 2', 'interventionNames': ['Drug: nonsteroid anti-inflammatory drops']}, {'type': 'EXPERIMENTAL', 'label': 'group 3', 'interventionNames': ['Drug: corticosteroids']}, {'type': 'OTHER', 'label': 'group 4', 'interventionNames': ['Drug: artificial tear substitute']}], 'interventions': [{'name': 'nonsteroid anti-inflammatory drops', 'type': 'DRUG', 'otherNames': ['prunoprefen'], 'description': 'nonsteroid anti-inflammatory drops plus artificial tear substitute', 'armGroupLabels': ['group 1']}, {'name': 'nonsteroid anti-inflammatory drops', 'type': 'DRUG', 'otherNames': ['bronuck'], 'description': 'nonsteroid anti-inflammatory drops plus artificial tear substitute', 'armGroupLabels': ['group 2']}, {'name': 'corticosteroids', 'type': 'DRUG', 'otherNames': ['Fluorometholone'], 'description': 'corticosteroids plus artificial tear substitute', 'armGroupLabels': ['group 3']}, {'name': 'artificial tear substitute', 'type': 'DRUG', 'description': 'artificial tear substitute alone', 'armGroupLabels': ['group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Eye Hospital, Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Wei Chen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Hospital, Wenzhou Medical College, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xiangtian Zhou', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}