Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-03-11 @ 9:26 PM
Study NCT ID:
NCT02992535
Status:
UNKNOWN
Last Update Posted:
2016-12-22
First Post:
2016-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-10', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear film osmolarity change', 'timeFrame': 'Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.', 'detailedDescription': 'Prospective study design among subjects with MGD and qualifying for IPL therapy.\n\nStudy testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).\n\nSubjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements.\n\nNo history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry eye\n* MGD\n\nExclusion Criteria:\n\n* No history of ocular infection or corneal degeneration/dystrophy\n* No history of corneal refractive surgery\n* No change in ocular medications in the last 2 months'}, 'identificationModule': {'nctId': 'NCT02992535', 'briefTitle': 'Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity', 'organization': {'class': 'OTHER', 'fullName': 'Carones Ophthalmology Center'}, 'officialTitle': 'Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).', 'orgStudyIdInfo': {'id': 'TLEUROPE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'Intense pulse light therapy (E-Schwin)', 'interventionNames': ['Device: Intense Pulse Light Energy delivery (IPL)']}], 'interventions': [{'name': 'Intense Pulse Light Energy delivery (IPL)', 'type': 'DEVICE', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Francesco Carones, MD', 'role': 'CONTACT', 'email': 'fcarones@carones.com', 'phone': '+390276318174'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carones Ophthalmology Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}