Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-05 @ 2:08 PM
Study NCT ID:
NCT03211351
Status:
COMPLETED
Last Update Posted:
2018-02-26
First Post:
2017-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479038', 'term': 'carbomer'}, {'id': 'D003911', 'term': 'Dextrans'}], 'ancestors': [{'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'scale of Schirmer I test', 'timeFrame': 'up to 3 months after tear substitutes apply'}, {'measure': 'scale of corneal fluorescein staining', 'timeFrame': 'up to 3 months after tear substitutes apply'}, {'measure': 'scale of noninvasive tear breakup time', 'timeFrame': 'up to 3 months after tear substitutes apply'}, {'measure': 'scale of tear meniscus height', 'timeFrame': 'up to 3 months after tear substitutes apply'}, {'measure': 'lipid layer grade', 'timeFrame': 'up to 3 months after tear substitutes apply'}, {'measure': 'questionnaire of ocular surface disease index', 'timeFrame': 'up to 3 months after tear substitutes apply'}], 'secondaryOutcomes': [{'measure': 'subjective comfort', 'timeFrame': 'up to 3 months after tear substitutes apply'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye', 'Tear Film', 'Lipid Layer', 'Liposic', 'Tears Naturale Forte']}, 'descriptionModule': {'briefSummary': 'With the potential to address evaporative dry eye, Liposic and Tears Naturale Forte have been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study compare the effects of Liposic and Tears Naturale Forte application on the lipid and stability of the tear film in dry eye patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age range from 20 year to 40 years\n* The value of OSDI is over 12\n* NBUT is less 5 seconds\n* Schirmer 1 test is less 10mm\n* The basical lipid layer grade is 1-2\n\nExclusion Criteria:\n\n* Any corneal,conjunctival, or eyelid abnormalities; conjunctivitis; current ocular infection; photophobia that may cause reflex tearing or difficulty in evaluating the patien 's lipid layer;\n* Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte"}, 'identificationModule': {'nctId': 'NCT03211351', 'briefTitle': 'Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Huaxia Eye Hospital Group'}, 'officialTitle': 'Comparison of the Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'FSHX-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposic', 'description': 'Liposic was applied to one eye of patients in this group', 'interventionNames': ['Drug: Liposic']}, {'type': 'EXPERIMENTAL', 'label': 'Tears Naturale Forte', 'description': 'Tears Naturale Forte was applied to one eye of patients in this group', 'interventionNames': ['Drug: Tears Naturale Forte']}], 'interventions': [{'name': 'Liposic', 'type': 'DRUG', 'otherNames': ['Carbomer'], 'description': 'one eye of the participant recieved Lipoic', 'armGroupLabels': ['Liposic']}, {'name': 'Tears Naturale Forte', 'type': 'DRUG', 'otherNames': ['DEXTRAN/HYPROMELLOSE/GLYCERIN'], 'description': 'the other eye of the participant recieved Tears Naturale Forte', 'armGroupLabels': ['Tears Naturale Forte']}]}, 'contactsLocationsModule': {'locations': [{'zip': '528000', 'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Huaxia Eye Hosptial of Foshan', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}], 'overallOfficials': [{'name': 'Chi Zhang, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huaxia Eye Hospital of Foshan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huaxia Eye Hospital Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}