KeratitisNCT00513734
A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill
A study testing Hydrogel dressing and Lacrilube ointment in people with Keratitis, run by Barts & The London NHS Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratitis
- What is being tested?
- Hydrogel dressing and Lacrilube ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Feb 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to Intensive care and expected to stay for more than 2 days
Who cannot join
- Primary orbital injury
About this study
Official title: Randomised Trial Comparing the Efficacy of Ocular Lubricant (Lacrilube) and Polyacrylamide Hydrogel Dressing (Geliperm) for the Prevention of Exposure Keratopathy in the Critically Ill
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.
- Conditions
- Keratitis
- Being tested
- Hydrogel dressing, Lacrilube ointment
- Keywords
- keratopathy, exposure, intensive care, eye, ulcer, Corneal
- Medical subject headings
- Keratitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel dressingOther
3x3cm hydrogel dressing over closed eye
Lacrilube ointmentOther
lubricant put into eye (inferior formix)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Geliperm Hydrogel Dressing Receives: Other: Hydrogel dressing |
| 2 | Active comparator | Lacrilube ointment Receives: Other: Lacrilube ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of clinically significant corneal exposure
Measured: throughout length of admission to ITU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startSep 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Marie Healy, FRCA, Study director, Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513734
- Sponsor's protocol ID
- 003171
- Status last verified
- Aug 2007
- First submitted
- 8 Aug 2007
- Last updated
- 9 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial Comparing the Efficacy of Ocular Lubricant (Lacrilube) and Polyacrylamide Hydrogel Dressing (Geliperm) for the Prevention of Exposure Keratopathy in the Critically Ill
- ClinicalTrials.gov ID
- NCT00513734
- Acronym / sponsor ID
- 003171
- Conditions
- Keratitis
- Keywords
- keratopathy, exposure, intensive care, eye, ulcer, Corneal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Feb 2005 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Hydrogel dressingGeliperm Hydrogel Dressing |
| 2 | Active comparator | Other: Lacrilube ointmentLacrilube ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to Intensive care and expected to stay for more than 2 days
Key exclusion criteria (1 listed)
- Primary orbital injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogel dressing3x3cm hydrogel dressing over closed eye | Other | 1 |
| Lacrilube ointmentlubricant put into eye (inferior formix) | Other | 2 |
Primary outcome
Development of clinically significant corneal exposure
Time frame: throughout length of admission to ITU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Healy, FRCA study director
Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogel dressing and Lacrilube ointment in people with Keratitis, run by Barts & The London NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of clinically significant corneal exposure (time frame: throughout length of admission to ITU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2007.