Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT05495958
Status:
UNKNOWN
Last Update Posted:
2022-08-10
First Post:
2022-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080343', 'term': 'Meibomian Gland Dysfunction'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index score', 'timeFrame': '3 months', 'description': 'The standard questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Tear breakup time (TBUT)', 'timeFrame': '3 months', 'description': 'time between fluorescein staining of the cul de sac and appearing dry island on the cornea'}, {'measure': 'schirmer1', 'timeFrame': '3 months', 'description': 'Millimeter of the standard strip wetting by tear of the patient'}, {'measure': 'Fluorescein staining test', 'timeFrame': '3 months', 'description': 'The number of fluorescein stained points on the cornea \\& conjunctiva based on Oxford classification score'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meibomian Gland Dysfunction']}, 'descriptionModule': {'briefSummary': 'In this randomized clinical trial, patients with Meibomian gland dysfunction aged 50 year and more will be enrolled. The Meibomian gland dysfunction diagnosis will confirmed by a cornea specialist. The enrolled patients will be randomly allocated to the treatment and placebo group. The patients in treatment group will receive topical vitamin D every 6 hours daily (25 Microgram/cc or 1000 IU). The control group will receive the same-shape packed drop without vitamin D. The patients in both group will receive the conventional treatment including hot compress and shampoo scrub.\n\nThe primary outcome is the change in Ocular surface disease index and 5-Item Dry Eye Questionnaire score assessed before the topical treatment and every one-months until 3 months. The secondary outcome measures are Tear breakup time, Schirmer test, Corneal fluorescein staining, Meibomian gland expressibility.\n\nThe grader and the patients will blind to the study group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.\n\nExclusion Criteria:\n\n* Patients with Vitamin D deficiency\n* Patients taking Vitamin D systemic Supplementation\n* Patient with prior ocular surgeries within previous 6 months.\n* Patient with other causes of dry eye, such as aqueous tear deficiency or ocular surface disease'}, 'identificationModule': {'nctId': 'NCT05495958', 'briefTitle': 'The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction', 'orgStudyIdInfo': {'id': '14014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Prescribe topical placebo eye drop', 'interventionNames': ['Drug: Topical placebo eye drop']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prescribe topical Vitamin D eye drop', 'interventionNames': ['Drug: Topical Vitamin D eye drop']}], 'interventions': [{'name': 'Topical Vitamin D eye drop', 'type': 'DRUG', 'description': '25 Microgram/cc or 1000 IU', 'armGroupLabels': ['Prescribe topical Vitamin D eye drop']}, {'name': 'Topical placebo eye drop', 'type': 'DRUG', 'description': 'The same-shape packed drop without vitamin D', 'armGroupLabels': ['Prescribe topical placebo eye drop']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Ophthalmic Research center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Ophthalmic Research Center', 'investigatorFullName': 'Zahra Rabbani Khah', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}