Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-30 @ 6:08 AM
Study NCT ID:
NCT05456061
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2022-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ADDE on Tear Interferometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2022-07-03', 'studyFirstSubmitQcDate': '2022-07-07', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average LLT (LLTave)', 'timeFrame': 'Baseline and one month after 1 month of treatments', 'description': 'LLT was measured using the LipiView® II tear interferometer (Johnson \\& Johnson, New Brunswick, New Jersey, USA). The tear interferometer automatically records 20-second videos reflecting the TFLL on the inferior cornea. Simultaneously, the quantified LLT is measured over time in the interferometric color unit (ICU). One ICU corresponds to approximately 1 nm of LLT. The LipiView® II interferometer provides the average, maximum, and minimum LLT values. The average LLT (LLTave) reflects the LLT value at the stable phase of the TFLL spreading or equilibrium state.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tear', 'Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'Importance: Lipid layer thickness (LLT) reflects the lipid components of tear film, but is affected by the mucocutaneous components. This study investigated the therapeutic effect of the treatments for aqueous-deficient dry eye (ADDE) on LLT.\n\nObjective: To investigate the effect of ADDE and its treatments on LLT measurements by tear interferometry.\n\nDesign, Setting, and Participants: This prospective comparative interventional study included 152 eyes from 152 patients with ADDE.\n\nInterventions: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).\n\nMain Outcomes and Measures: Average LLT (LLTave) was measured using a LipiView® II tear interferometer at baseline and one month after treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.\n2. tear meniscus height (TMH) of \\<200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).\n3. evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.\n\nExclusion Criteria:\n\n1. acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.\n2. a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.\n3. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.\n4. Hypersecretory meibomian gland dysfunction (MGD)\n\n * When both eyes of a patient could be included, an eye with the lower TMH was selected."}, 'identificationModule': {'nctId': 'NCT05456061', 'briefTitle': 'Effect of ADDE on Tear Interferometry', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements', 'orgStudyIdInfo': {'id': '4-2018-0634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1', 'description': 'No intervention'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '3% diquafosol eye drops 6 times / day', 'interventionNames': ['Drug: 3% diquafosol eyedrops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Punctal plug insertion, lower eyelid', 'interventionNames': ['Procedure: Silicone punctal plug insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4', 'description': '3% diquafosol eye drops 6 times / day + Punctal plug insertion, lower eyelid', 'interventionNames': ['Drug: 3% diquafosol eyedrops', 'Procedure: Silicone punctal plug insertion']}], 'interventions': [{'name': '3% diquafosol eyedrops', 'type': 'DRUG', 'description': 'Diquas® (Santen, Osaka, Japan), six times per day.', 'armGroupLabels': ['Group 2', 'Group 4']}, {'name': 'Silicone punctal plug insertion', 'type': 'PROCEDURE', 'description': 'a silicone punctal occluder (Parasol® Punctal Occluder, BVI, Waltham, Massachusetts, USA), inserted into the lower eyelid', 'armGroupLabels': ['Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Kyoung Yul Seo', 'investigatorAffiliation': 'Yonsei University'}}}}