Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-13 @ 5:05 AM
Study NCT ID:
NCT02992392
Status:
UNKNOWN
Last Update Posted:
2016-12-15
First Post:
2016-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Clinical 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': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2016-12-12', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, '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', 'description': 'Subjective comfort was established at each time-point by asking subjects, firstly, to relate their comfort to baseline in each eye (more comfortable/no different/less comfortable) . secondly, to express a preference for their more comfortable eye (right eye/left eye/no difference)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tear film', 'Lipid layer', 'Liposic', 'Tears Naturale Forte'], 'conditions': ['Dry Eye']}, '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* Minimum age of 20 years(range from 20 year to 25 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 patient's lipid layer;\n* Known allergic sensitivity to any of the ingredients in Liposic or Tears Naturale Forte"}, 'identificationModule': {'nctId': 'NCT02992392', 'briefTitle': 'Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Comparison of the Clinical Effects of Two Tear Substitutes in Patients With Dry Eye Syndrome', 'orgStudyIdInfo': {'id': '2016-007'}}, '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': '570311', 'city': 'Haikou', 'state': 'Hainan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingwu Zhong, MD,PhD', 'role': 'CONTACT', 'email': 'zhongxwu@mail.sysu.edu.cn', 'phone': '+86(898)68628481'}], 'facility': 'Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}], 'centralContacts': [{'name': 'Chi Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'mike0946@163.com'}], 'overallOfficials': [{'name': 'Xingwu Zhong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xingwu Zhong, MD PhD', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}