Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-06 @ 12:55 PM
Study NCT ID:
NCT03608761
Status:
COMPLETED
Last Update Posted:
2018-12-04
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Rebamipide 2% Versus Autologous Serum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C052785', 'term': 'rebamipide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-02', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OSDI', 'timeFrame': 'through study completion, an average of 7 months', 'description': 'ocular surface disease index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dry eye', 'Sjögren syndrome', 'Rebamipida 2%', 'autologous serum'], 'conditions': ['Dry Eye Syndromes', 'Sjögren Syndrome']}, 'descriptionModule': {'briefSummary': "Two-period, controlled, randomized and open clinical trial. The sample was composed of adult women with moderate to severe hypo secretory dry eye associated with Sjögren's syndrome, who attended the ocular surface office, derived from the general ophthalmology clinic, from the Rheumatology or Immunology department. The three interventions were randomized: autologous serum (GSA), Rebamipida 2% (GR) and a combined treatment (GSAR). The following were used as outcome measures: OSDI self-administered questionnaire (Ocular Surface Disease Index), tear-rupture time (BUT), fluorescein staining, Bengal Rose staining and Schirmer's test without anesthesia to assess the answer to each treatment", 'detailedDescription': 'After having borrowed to participate in the study, we proceeded to the random assignment of each intervention as follow: the last 2 numbers of the clinical history, typical of the ocular surface office, were taken and they were placed in a list in order of lower to higher. Then, each of them was assigned to a number from a table of random numbers. The list was rearranged from lowest to highest using the assigned random number. Finally, the treatment was assigned by simple randomization without replacement. In this way, the subject with the lowest random number, the correspondence in the first treatment drawn. It was continued in the same way, respecting the order assigned by random numbers until completing the 21 subjects.\n\nThree groups of 7 subjects each were formed in this way: treatment group or group Rebamipida (GR); standard treatment group or autologous serum group (GSA) and mixed group or serum and Rebamipide group (GSAR).\n\nBefore beginning with the assigned treatment, all the participants was started a period of wash-out of any medicine they were ussing, that least for two weeks. The participants were asked to suspend all the drops that they been used until then (antibiotics, corticosteroids, cyclosporine, artificial tears, autologous serum, etc.), and to place them using only artificial tears (sodium carboxymethyl cellulose). 1%, AUCIC 1%) four times a day in all cases. The purpose was to minimize the effect of the medication that could interfere with the results obtained from the treatments tested. The two week period also allowed the hemotherapy service to prepare the autologous serum for the subjects assigned to this group and initiate the treatment without delays.\n\nImmediately after the washout period, the subjects began to receive the last treatments for 90 days.\n\nAfter the first intervention cycle and with the objective of influencing the treatment cycle of the first treatment cycle, a second washing period of two weeks duration was carried out.\n\nWith the intention of increasing the sample size, the GR and GSA groups were crossed, in this way the patients received the opposite treatment to the start. The second treatment period lasted 90 days, equal to the first.\n\nThe mixed group (GSAR) did not cross, ending their participation at the end of the 90 days.\n\nAdmission and control of all patients on days 0, 30 and 90 of both cycles were performed by the same ophthalmologist.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosis of Sjögren's syndrome\n* dry eye symtoms\n\nExclusion Criteria:\n\n* history of ocular surface surgery less than one year or intraocular surgery less than three months in one or both eyes\n* chronic use of drops in one of both eyes (e.g. : treatment for glaucoma)\n* anterior segment disease (ocular scar pemphigoid, Stenvens Jhonson syndrome)\n* presence of punctung plug (lacrimal plug) inserted in one or both lower lacrimal points\n* systemic viral infections (Hepatitis B, Hepatitis C, HIV)"}, 'identificationModule': {'nctId': 'NCT03608761', 'briefTitle': 'Comparison Between Rebamipide 2% Versus Autologous Serum', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Nacional Profesor Alejandro Posadas'}, 'officialTitle': 'Comparison Between Rebamipide 2% Versus Autologous Serum in the Treatement of the Moderate to Severe Dry Eye Associate With Sjögren Syndrome. Pilot, Crossed, Controled, Randomized And Open Study', 'orgStudyIdInfo': {'id': '055LuPeSo/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rebamipide 2%', 'description': '1. \\- wash-out: 2 weeks\n2. \\- rebamipide 2% four times a day for 3 months\n3. \\- controls will be taken at day zero, 30 and 90.\n4. \\- wash-out: 2 weeks\n5. \\- autologous serum for 3 months', 'interventionNames': ['Drug: Rebamipide']}, {'type': 'EXPERIMENTAL', 'label': 'Autologous serum', 'description': '1. \\- wash-out: 2 weeks\n2. \\- autologous serum four times a day for 3 months\n3. \\- controls will be taken at day zero, 30 and 90.\n4. \\- wash-out: 2 weeks\n5. \\- rebamipe 2% for 3 months', 'interventionNames': ['Biological: autologous serum']}, {'type': 'EXPERIMENTAL', 'label': 'autologous serum and rebamipide 2%', 'description': 'rebamipide 2% and autologous serum four times a day for 3 months separately by 1 minute between each other controls will be taken at day zero, 30 and 90. this group will not be crossed', 'interventionNames': ['Other: autologous serum and rebamipide 2%']}], 'interventions': [{'name': 'Rebamipide', 'type': 'DRUG', 'otherNames': ['GR'], 'description': 'rebamipide 2%', 'armGroupLabels': ['Rebamipide 2%']}, {'name': 'autologous serum', 'type': 'BIOLOGICAL', 'otherNames': ['GSA'], 'description': 'AS for 3 months', 'armGroupLabels': ['Autologous serum']}, {'name': 'autologous serum and rebamipide 2%', 'type': 'OTHER', 'otherNames': ['GSAR'], 'description': 'rebamipide and autologous serum for 3 months', 'armGroupLabels': ['autologous serum and rebamipide 2%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1684', 'city': 'El Palomar', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Nacional Profesor A. Posadas', 'geoPoint': {'lat': -34.61771, 'lon': -58.60153}}], 'overallOfficials': [{'name': 'Emiliano Fa Ross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nacional Profesor Alejandro Posadas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Nacional Profesor Alejandro Posadas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}