CClinicalTrials.gg
CompletedNCT00513734Updated Aug 9, 2007

A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill

An interventional study of Hydrogel dressing and Lacrilube ointment in Keratitis, sponsored by Barts & The London NHS Trust. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-08-09.

Sponsored by Barts & The London NHS Trust · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Microbial keratitis, particularly pseudomonas-related, has been widely reported amongst Intensive therapy unit (ITU) patients and the need for effective eye care in ITU has been recognised for some time. We compare two popular methods of eye care; a hydrogel dressing and lacrilube ointment. Each recruited patient had each eye randomised to different treatments. Daily ophthalmology ward rounds were undertaken to identify any corneal exposure keratopathy. Patients were removed from the trial if one eye developed significant exposure needing treatment.

02

Conditions studied

  • Keratitis

Browse trials for

Keywords

  • keratopathy
  • exposure
  • intensive care
  • eye
  • ulcer
  • Corneal
03

In context

Keratitis

126 studies on the registry are indexed under Keratitis; 15 are open to participants now.

This study's enrollment of 40 is above the median of 36 across 79 interventional studies indexed under Keratitis.

Browse Keratitis studies →

Lead sponsor

Barts & The London NHS Trust is the lead sponsor of 149 studies on the registry; 21 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Primary orbital injury
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    1

    Geliperm Hydrogel Dressing

    Other: Hydrogel dressing

  • Active comparator
    2

    Lacrilube ointment

    Other: Lacrilube ointment

Interventions

  • OtherHydrogel dressing

    3x3cm hydrogel dressing over closed eye

  • OtherLacrilube ointment

    lubricant put into eye (inferior formix)

06

What researchers measure

Primary outcomes

  1. Development of clinically significant corneal exposure

    Time frame: throughout length of admission to ITU

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00513734
Lead sponsor
Barts & The London NHS Trust
First posted
Aug 9, 2007
Start date
Sep 2004
Completion
Feb 2005
Last update
Aug 9, 2007

Study contacts

Marie Healy, FRCA
study director · Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion