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Effect of Nursing Care on Prevention of Dry Eye

Primary Purpose

Dry Eye Syndromes

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
LACRIBELL®
VIDISIC® GEL
Sponsored by
Diego Dias de Araújo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Eye Syndromes focused on measuring Dry eye, Diseases of the eye and adnexa

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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%.

Sites / Locations

  • Santa de Misericórdia Montes ClarosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sham Comparator: Eye drop

VIDISIC® GEL

Arm Description

Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing.

Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2016
Last Updated
February 13, 2017
Sponsor
Diego Dias de Araújo
Collaborators
State University of Montes Claros, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02767258
Brief Title
Effect of Nursing Care on Prevention of Dry Eye
Official Title
Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Diego Dias de Araújo
Collaborators
State University of Montes Claros, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry eye, Diseases of the eye and adnexa

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Comparator: Eye drop
Arm Type
Active Comparator
Arm Description
Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing.
Arm Title
VIDISIC® GEL
Arm Type
Experimental
Arm Description
Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border.
Intervention Type
Device
Intervention Name(s)
LACRIBELL®
Other Intervention Name(s)
liquid artificial tears, eyedrop
Intervention Description
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
Intervention Type
Device
Intervention Name(s)
VIDISIC® GEL
Other Intervention Name(s)
artificial tear gel
Intervention Description
Carbomer based gel, used in the treatment of dry eye.
Primary Outcome Measure Information:
Title
Dry Eye
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.
Time Frame
Five consecutive days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego D Araújo, PhD student
Phone
55 (38) 3213 2150
Ext
Brazil
Email
diego.dias1508@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tânia CM Chianca, PhD
Phone
55 (31) 3409 9887
Ext
Brazil
Email
taniachianca@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diego D Araújo, PhD student
Organizational Affiliation
State University of Montes Claros, Minas Gerais, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa de Misericórdia Montes Claros
City
Montes Claros
State/Province
Minas Gerais
ZIP/Postal Code
39402-218
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Dias de Araújo
Phone
(38)3213-2150
Email
diego.dias1508@gmail.com
First Name & Middle Initial & Last Name & Degree
Diego Dias de Araújo

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan 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.
Citations:
PubMed Identifier
27192415
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.
Results Reference
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Effect of Nursing Care on Prevention of Dry Eye

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