Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02894658
Status:
WITHDRAWN
Last Update Posted:
2023-02-16
First Post:
2016-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipiflow Versus Warm Compresses in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of equipment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-09-03', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meibomian gland assessment defined as assessment of 15 glands on the lower eyelid margin using a handheld instrument, the Meibomian Gland Evaluator.', 'timeFrame': 'Four visits up to three months', 'description': 'Expressed secretion characteristics graded on a scale:\n\n3 (clear liquid secretion)\n\n2 (cloudy liquid secretion)\n\n1 (inspissated/toothpaste consistency)\n\n0 (no secretion)\n\nMeibomian gland metrics will be calculated:\n\nA) Total meibomian gland score (sum of the grades for all 15 glands with a range from 0 to 45)\n\nB) The number of glands secreting any liquid (clear or cloudy liquid with a grade of 2 or 3) of the 15 glands assessed\n\nC) The number of glands yielding the optimal clear liquid secretion (clear liquid with a grade of 3) of the 15 glands assessed.'}], 'secondaryOutcomes': [{'measure': 'Tear break up time', 'timeFrame': 'Four visits up to three months', 'description': 'Tear break up time defined measured with the fluorescein tear break up time (FBUT) method and categorized as follows\n\n* "Dry" defined as FBUT values of 1-5 seconds\n* "Marginal" defined as FBUT of 6-9 seconds\n* "Normal" defined as FBUT of 10 or greater seconds'}, {'measure': 'Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment', 'timeFrame': 'Four visits up to three months', 'description': 'The OSDI score is assessed on a scale of 0 to 100 with higher scores representing greater disability.'}, {'measure': 'Best spectacle-corrected visual acuity (BSCVA) with high-contrast Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart using the ETDRS-Fast method under standard illumination', 'timeFrame': 'Four visits up to three months'}, {'measure': 'Corneal Staining', 'timeFrame': 'Four visits up to three months', 'description': '• Corneal staining\n\n* Evaluated with a slit-lamp biomicroscope 90 seconds after instillation of fluorescein dye using a standard strip method\n* Corneal staining is based on the Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye and will be graded on a scale of 0 (none) - 3 (severe) with a total corneal staining grade range from 0 to 15'}, {'measure': 'SPEED Questionnaire assessment of dry eye symptoms before and after treatment', 'timeFrame': 'Four visits up to three months', 'description': 'SPEED Questionnaire rating of types, frequency, and severity of symptoms. Frequency is grade 0 to 3. Severity is grade 0 to 4. Higher grades represent greater disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Meibomian Gland Dysfunction']}, 'descriptionModule': {'briefSummary': 'The LipiFlow System (TearScience, Morrisville, NC) is an in-office FDA approved treatment for meibomian gland dysfunction. It relieves meibomian gland obstruction through the use of heat and pulsatile pressure. A recent study has observed that a single treatment with the LipiFlow system can decrease dry eye symptoms and objective findings of meibomian gland dysfunction for 1 year. We aim to see if the Lipiflow System will be beneficial in patients with Parkinsons disease who may have difficulty performing normal meibomian gland dysfunction treatment.', 'detailedDescription': 'Objectives To determine whether a single treatment with thermal pulsation relieves dry eye symptoms (primary objective) and improves objective findings of meibomian gland dysfunction in patients with Parkinsons disease.\n\nMethods and Measures\n\nDesign\n\n* Randomized, controlled trial\n* Patient eyes will be randomized to either receive a single thermal pulsation treatment the FDA-approved Lipiflow thermal pulsation system or to use traditional eyelid hygiene or to use traditional eyelid hygiene'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with Parkinsons disease and dry eye attributed to meibomian gland dysfunction\n\nInclusion Criteria:\n\n* Medical diagnosis of Parkinsons disease\n* \\> 18 years-old\n* Reported dry eye symptoms within 3 months of baseline examination with a Standard Patient Evaluation for Eye Dryness (SPEED) score ≥ 6 at baseline visit\n* Evidence of meibomian gland obstruction (based on a total meibomian gland secretion score of ≤ 12 for 15 glands of the lower lid)\n* Willingness to stop dry eye medications including antibiotics, non-steroidal and anti-inflammatory drugs, and corticosteroids for 2 weeks prior to treatment and during the duration of the study\n\nExclusion Criteria:\n\n* Active intraocular inflammation\n* Ocular surface abnormality that could potentially compromise corneal integrity in either eye'}, 'identificationModule': {'nctId': 'NCT02894658', 'briefTitle': "Lipiflow Versus Warm Compresses in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Prospective Fellow Eye Comparison of Traditional Meibomian Gland Disease Treatment Versus a Single Thermal Pulsation Treatment in Patients With Parkinsons Disease', 'orgStudyIdInfo': {'id': 'IRB00033387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lipiflow system', 'description': 'Treatment through the use of heat and pulsatile pressure.', 'interventionNames': ['Device: LipiFlow system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fellow eye warm compresses', 'description': 'Warm compresses to fellow eye and daily treatment with eyelid scrubs.', 'interventionNames': ['Procedure: Warm compresses']}], 'interventions': [{'name': 'LipiFlow system', 'type': 'DEVICE', 'description': 'LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.', 'armGroupLabels': ['Lipiflow system']}, {'name': 'Warm compresses', 'type': 'PROCEDURE', 'description': 'Warm compresses will be applied to fellow eye and that eye will undergo daily treatment with eyelid scrubs using a warm wash cloth and "no tears" baby shampoo every morning and warm compresses on the eyelids for 5-10 minutes twice a day. Patients will be instructed on how to perform proper lid hygiene at the initial visit.', 'armGroupLabels': ['Fellow eye warm compresses']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susan Burden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest Baptist Health Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}