Effect of Nursing Care on Prevention of Dry Eye
Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 14, 2017
February 1, 2017
1.7 years
May 6, 2016
February 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dry Eye
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.
Five consecutive days
Study Arms (2)
Sham Comparator: Eye drop
ACTIVE COMPARATOREye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing.
VIDISIC® GEL
EXPERIMENTALOcular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border.
Interventions
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
Carbomer based gel, used in the treatment of dry eye.
Eligibility Criteria
You may qualify if:
- Be over 18 years;
- Did not present dry eye at the time of admission;
- Stay in the ICU for at least 24 hours;
- Be in mechanical ventilation therapy;
- Glance less than 5 per minute;
- Comatose, sedated or Glasgow less than or equal to 7;
- Consent to participate in research or have.
You may not qualify if:
- Have not the responsabille authorization;
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Santa de Misericórdia Montes Claros
Montes Claros, Minas Gerais, 39402-218, Brazil
Related Publications (1)
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.
PMID: 27192415BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diego D Araújo, PhD student
State University of Montes Claros, Minas Gerais, Brazil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Teacher and Student Doctoral Nursing
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 10, 2016
Study Start
May 1, 2016
Primary Completion
December 31, 2017
Study Completion
December 31, 2019
Last Updated
February 14, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share
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.