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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00513734
Other study ID # 003171
Secondary ID
Status Completed
Phase N/A
First received August 8, 2007
Last updated August 8, 2007
Start date September 2004
Est. completion date February 2005

Study information

Verified date August 2007
Source Barts & The London NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Primary orbital injury

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Hydrogel dressing
3x3cm hydrogel dressing over closed eye
Lacrilube ointment
lubricant put into eye (inferior formix)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Barts & The London NHS Trust

Outcome

Type Measure Description Time frame Safety issue
Primary Development of clinically significant corneal exposure throughout length of admission to ITU
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