Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT02767258
Status:
UNKNOWN
Last Update Posted:
2017-02-14
First Post:
2016-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nursing Care on Prevention of Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2016-05-06', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dry Eye', 'timeFrame': 'Five consecutive days', 'description': 'Interventions will be applied in both eyes of the patients from 12 to 12 hours for five consecutive days. Schirmer test will be applyed to evaluate the lacrimal volume. Fluorescein test will be applyed to evaluate the ocular surface.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye', 'Diseases of the eye and adnexa'], 'conditions': ['Dry Eye Syndromes']}, 'referencesModule': {'references': [{'pmid': '27192415', 'type': 'BACKGROUND', 'citation': 'de Araujo DD, Almeida NG, Silva PM, Ribeiro NS, Werli-Alvarenga A, Chianca TC. Prediction of risk and incidence of dry eye in critical patients. Rev Lat Am Enfermagem. 2016;24:e2689. doi: 10.1590/1518-8345.0897.2689. Epub 2016 May 17.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU.', 'detailedDescription': 'Critically ill patients are at higher risk for dry eye and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. Thus, the general objective of this study was to evaluate the risk for developing dry eye in critically ill patients and the effectiveness of three types of interventions: eye gel and eyedrops (control group). The specific objectives were: verify the most effective intervention for the prevention of dry eye from the available literature and provided by: eye gel compared to the control group eyedrops who received eye care through randomized controlled clinical trial. Patients and methods: This study is a randomized controlled trial to determine the best care for the prevention of dry eye from those available on the market (eye drops and eye gel), in the period from 14/01/2016 to 31/12/2019 . The expected result is: negative values in Schirmer test and no corneal ulcers presence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 18 years;\n* Did not present dry eye at the time of admission;\n* Stay in the ICU for at least 24 hours;\n* Be in mechanical ventilation therapy;\n* Glance less than 5 per minute;\n* Comatose, sedated or Glasgow less than or equal to 7;\n* Consent to participate in research or have.\n\nExclusion Criteria:\n\n* Have not the responsabille authorization;\n* Patients with severe eye disease or with history of adverse effects after use of any of the interventions proposed and not tolerate the treatment: artificial tear gel, artificial tear liquid and saline 0.9%.'}, 'identificationModule': {'nctId': 'NCT02767258', 'briefTitle': 'Effect of Nursing Care on Prevention of Dry Eye', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'EE/UFMG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sham Comparator: Eye drop', 'description': 'Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing.', 'interventionNames': ['Device: LACRIBELL®']}, {'type': 'EXPERIMENTAL', 'label': 'VIDISIC® GEL', 'description': 'Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border.', 'interventionNames': ['Device: VIDISIC® GEL']}], 'interventions': [{'name': 'LACRIBELL®', 'type': 'DEVICE', 'otherNames': ['liquid artificial tears', 'eyedrop'], 'description': 'Hypromellose and dextran based eyedrop, used in the treatment of dry eye.', 'armGroupLabels': ['Sham Comparator: Eye drop']}, {'name': 'VIDISIC® GEL', 'type': 'DEVICE', 'otherNames': ['artificial tear gel'], 'description': 'Carbomer based gel, used in the treatment of dry eye.', 'armGroupLabels': ['VIDISIC® GEL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39402-218', 'city': 'Montes Claros', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Diego Dias de Araújo', 'role': 'CONTACT', 'email': 'diego.dias1508@gmail.com', 'phone': '(38)3213-2150'}, {'name': 'Diego Dias de Araújo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Santa de Misericórdia Montes Claros', 'geoPoint': {'lat': -16.735, 'lon': -43.86167}}], 'centralContacts': [{'name': 'Diego D Araújo, PhD student', 'role': 'CONTACT', 'email': 'diego.dias1508@gmail.com', 'phone': '55 (38) 3213 2150', 'phoneExt': 'Brazil'}, {'name': 'Tânia CM Chianca, PhD', 'role': 'CONTACT', 'email': 'taniachianca@gmail.com', 'phone': '55 (31) 3409 9887', 'phoneExt': 'Brazil'}], 'overallOfficials': [{'name': 'Diego D Araújo, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of Montes Claros, Minas Gerais, Brazil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diego Dias de Araújo', 'class': 'OTHER'}, 'collaborators': [{'name': 'State University of Montes Claros', 'class': 'UNKNOWN'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Teacher and Student Doctoral Nursing', 'investigatorFullName': 'Diego Dias de Araújo', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}