KeratitisCORNEALPREVNCT02293876
Corneal Lesions in Intensive Care Unit (ICU) Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center Clinical Trial for Proposing Interventions and Evaluating Outcomes of Nursing in the Adult Intensive Care Center
A study testing LACRIBELL®, LIPOSIC® and Glad wrap in people with Keratitis and Corneal Ulcer, run by Hospital Risoleta Tolentino Neves at 1 site in Brazil.
Trial summary
The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 to 93 years
- Conditions the study is for
- Keratitis, Corneal Ulcer
- What is being tested?
- LACRIBELL®, LIPOSIC® and Glad wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Nov 2014
- 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 to 93 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 48 hours in Intensive Care Unit
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Risoleta Tolentino Neves
Belo Horizonte, Minas Gerais, 31744012
About this study
Official title: Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial
The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit.
Read the detailed description
Critically ill patients are at higher risk for corneal injury and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. There is a scale for assessing the risk for corneal injury. Thus, the general objective of this study was to evaluate the risk for developing corneal injury in critically ill patients and the effectiveness of three types of interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its prevention. The specific objectives were: verify the most effective intervention for the prevention of corneal injury from the available literature and provided by: eye gel, eyedrops and polyethylene film compared to the control group who received eye care through randomized controlled clinical trial. Patients and methods: This study was a randomized controlled trial to determine the best care for the prevention of corneal injury from those available on the market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in the period from 09/07/2013 to 03/15/2014 .
- Conditions
- Keratitis, Corneal Ulcer
- Being tested
- LACRIBELL®, LIPOSIC®, Glad wrap
- Keywords
- Corneal Diseases, Corneal Ulcer, Nursing Diagnosis, Intensive Care Units, Nursing, Randomized Clinical Trial
- Medical subject headings
- Keratitis, Corneal Ulcer, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACRIBELL®Device
Also called Eyedrop
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
LIPOSIC®Device
Also called Occular Gel
Carbomer and Sorbitol based gel, used in the treatment of dry eye.
Glad wrapDevice
Also called Polyethylene film
A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.
| Study group | Role | What they receive |
|---|---|---|
| Eye drop | Sham comparator | Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing. Receives: 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. Receives: Device: LIPOSIC® |
| Glad wrap | Sham comparator | Occlusion of the orbital area with a Glad wrap, turning the area into a moisture chamber. Receives: Device: Glad wrap |
| Control group | No intervention | Ocular cleansing three times a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratitis
Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.
Measured: Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionNov 2014
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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Risoleta Tolentino Neves
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Andreza Werli Alvarenga, Hospital Risoleta Tolentino Neves
- Investigators
- Andreza Werli-Alvarenga, RN, MD, PhD, Principal investigator, Hospital Risoleta Tolentino Neves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293876
- Sponsor's protocol ID
- ICU CORNEAL ULCER 01
- Acronym
- CORNEALPREV
- Status last verified
- Nov 2014
- First submitted
- 14 Nov 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk for Corneal Injury in Critically Ill Patients and Effect of Nursing Interventions for Its Prevention: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02293876
- Acronym / sponsor ID
- CORNEALPREV / ICU CORNEAL ULCER 01
- Conditions
- Keratitis, Corneal Ulcer
- Keywords
- Corneal Diseases, Corneal Ulcer, Nursing Diagnosis, Intensive Care Units, Nursing, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Hospital Risoleta Tolentino NevesUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Nov 2014 (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.
The purpose of the study is find out the better measure to achieve corneal protection in an Intensive Care Unit.
Detailed description
Critically ill patients are at higher risk for corneal injury and the mechanisms responsible for ocular lubrication and protection can be compromised. However, the literature diverges on which is the best clinical practice for treatment. There is a scale for assessing the risk for corneal injury. Thus, the general objective of this study was to evaluate the risk for developing corneal injury in critically ill patients and the effectiveness of three types of interventions: eye gel, eyedrops and polyethylene film, compared to the control group in its prevention. The specific objectives were: verify the most effective intervention for the prevention of corneal injury from the available literature and provided by: eye gel, eyedrops and polyethylene film compared to the control group who received eye care through randomized controlled clinical trial. Patients and methods: This study was a randomized controlled trial to determine the best care for the prevention of corneal injury from those available on the market (eye drops, eye gel and polyethylene film), compared to a control group (eye care) in the period from 09/07/2013 to 03/15/2014 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eye drop | Sham comparator | Device: LACRIBELL®Eye drop LACRIBELL® - two drops each eye, three times a day, after eye cleansing. |
| Ocular gel | Sham comparator | Device: LIPOSIC®Ocular gel LIPOSIC® applied three times a day at the lower palpebra from medium line to the lateral border. |
| Glad wrap | Sham comparator | Device: Glad wrapOcclusion of the orbital area with a Glad wrap, turning the area into a moisture chamber. |
| Control group | No intervention | –Ocular cleansing three times a day. |
Who may qualify
- Ages
- 18 to 93 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 48 hours in Intensive Care Unit
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 |
|---|---|---|
| LACRIBELL®Also: EyedropHypromellose and dextran based eyedrop, used in the treatment of dry eye. | Device | Eye drop |
| LIPOSIC®Also: Occular GelCarbomer and Sorbitol based gel, used in the treatment of dry eye. | Device | Ocular gel |
| Glad wrapAlso: Polyethylene filmA clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber. | Device | Glad wrap |
Primary outcome
Keratitis
Time frame: Five days
Presence of keratitis visible with a cobalt light ophthalmoscope and fluorescein eye drop.
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 19 Nov 2014.
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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.
Andreza Werli-Alvarenga, RN, MD, PhD principal investigator
Hospital Risoleta Tolentino Neves
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LACRIBELL®, LIPOSIC® and Glad wrap in people with Keratitis and Corneal Ulcer, run by Hospital Risoleta Tolentino Neves at 1 site in Brazil.
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 4 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 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Keratitis (time frame: Five days). 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 19 Nov 2014.