NCT00513734

Brief Summary

Corneal damage in critically ill patients is common. There are currently two popular methods of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise patients to have a different treatment for each eye and see which one is more effective.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2004

Shorter than P25 for not_applicable

Status
completed

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

September 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
Last Updated

August 9, 2007

Status Verified

August 1, 2007

First QC Date

August 8, 2007

Last Update Submit

August 8, 2007

Conditions

Keratitis

Keywords

keratopathyexposureintensive careeyeulcerCorneal

Outcome Measures

Primary Outcomes (1)

  • Development of clinically significant corneal exposure

    throughout length of admission to ITU

Study Arms (2)

1

ACTIVE COMPARATOR

Geliperm Hydrogel Dressing

Other: Hydrogel dressing

2

ACTIVE COMPARATOR

Lacrilube ointment

Other: Lacrilube ointment

Interventions

Hydrogel dressingOTHER

3x3cm hydrogel dressing over closed eye

1
Lacrilube ointmentOTHER

lubricant put into eye (inferior formix)

2

Eligibility Criteria

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

You may qualify if:

  • All patients admitted to Intensive care and expected to stay for more than 2 days

You may not qualify if:

  • Primary orbital injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

KeratitisUlcer

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Marie Healy, FRCA

    Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

September 1, 2004

Study Completion

February 1, 2005

Last Updated

August 9, 2007

Record last verified: 2007-08