NCT02293876

Brief Summary

The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 14, 2014

Last Update Submit

November 18, 2014

Conditions

KeratitisCorneal Ulcer

Keywords

Corneal DiseasesCorneal UlcerNursing DiagnosisIntensive Care UnitsNursingRandomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • Keratitis

    Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.

    Five days

Study Arms (4)

Eye drop

SHAM COMPARATOR

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

Device: LACRIBELL®

Ocular gel

SHAM COMPARATOR

Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border.

Device: LIPOSIC®

Glad wrap

SHAM COMPARATOR

Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber.

Device: Glad wrap

Control group

NO INTERVENTION

Ocular cleansing three times a day.

Interventions

LACRIBELL®DEVICE

Hypromellose and dextran based eyedrop, used in the treatment of dry eye.

Also known as: Eyedrop
Eye drop
LIPOSIC®DEVICE

Carbomer and Sorbitol based gel, used in the treatment of dry eye.

Also known as: Occular Gel
Ocular gel
Glad wrapDEVICE

A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.

Also known as: Polyethylene film
Glad wrap

Eligibility Criteria

Age18 Years - 93 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ramsay sedation scale 5 or 6
  • Glasgow coma scale lower than 7
  • Use of oxygen therapy by facial device above 6 liters per minute or mechanical ventilation
  • Blink reflex less than 5 times per minute or ocular globe exposure

You may not qualify if:

  • Less than 48 hours in Intensive Care Unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Risoleta Tolentino Neves

Belo Horizonte, Minas Gerais, 31744012, Brazil

Location

MeSH Terms

Conditions

KeratitisCorneal UlcerCorneal Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesEye InfectionsInfections

Study Officials

  • Andreza Werli-Alvarenga, RN, MD, PhD

    Hospital Risoleta Tolentino Neves

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MD, PhD

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 18, 2014

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

November 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

BR(1)