Dry Eye SyndromesNCT02767258
Effect of Nursing Care on Prevention of Dry Eye
A study testing LACRIBELL® and VIDISIC® GEL in people with Dry Eye Syndromes, run by Diego Dias de Araújo at 1 site in Brazil.
Trial summary
Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- LACRIBELL® and VIDISIC® GEL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2016to 31 Dec 2019
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be over 18 years;
- Did not present dry eye at the time of admission;
- Stay in the ICU for at least 24 hours;
- Be in mechanical ventilation therapy;
- Glance less than 5 per minute;
- Comatose, sedated or Glasgow less than or equal to 7;
- Consent to participate in research or have.
Who cannot join
- Have not the responsabille authorization;
- Patients with severe eye disease or with history of adverse effects after use of any of the interventions proposed and not tolerate the treatment: artificial tear gel, artificial tear liquid and saline 0.9%.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa de Misericórdia Montes Claros
Montes Claros, Minas Gerais, 39402-218
Diego Dias de Araújo, (38)3213-2150, diego.dias1508@gmail.com
Diego Dias de Araújo
About this study
Official title: Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients
Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU.
Read the detailed description
Critically ill patients are at higher risk for dry eye 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. Thus, the general objective of this study was to evaluate the risk for developing dry eye in critically ill patients and the effectiveness of three types of interventions: eye gel and eyedrops (control group). The specific objectives were: verify the most effective intervention for the prevention of dry eye from the available literature and provided by: eye gel compared to the control group eyedrops who received eye care through randomized controlled clinical trial. Patients and methods: This study is a randomized controlled trial to determine the best care for the prevention of dry eye from those available on the market (eye drops and eye gel), in the period from 14/01/2016 to 31/12/2019 . The expected result is: negative values in Schirmer test and no corneal ulcers presence.
- Conditions
- Dry Eye Syndromes
- Being tested
- LACRIBELL®, VIDISIC® GEL
- Keywords
- Dry eye, Diseases of the eye and adnexa
- Medical subject headings
- Dry Eye Syndromes, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACRIBELL®Device
Also called liquid artificial tears, eyedrop
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
VIDISIC® GELDevice
Also called artificial tear gel
Carbomer based gel, used in the treatment of dry eye.
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator: Eye drop | Active comparator | Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing. Receives: Device: LACRIBELL® |
| VIDISIC® GEL | Experimental | Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border. Receives: Device: VIDISIC® GEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye
Interventions will be applied in both eyes of the patients from 12 to 12 hours for five consecutive days. Schirmer test will be applyed to evaluate the lacrimal volume. Fluorescein test will be applyed to evaluate the ocular surface.
Measured: Five consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start1 May 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diego Dias de Araújo
- Sponsor type
- University, hospital or other
- Collaborators
- State University of Montes Claros, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor-investigator, Diego Dias de Araújo, Federal University of Minas Gerais
- Investigators
- Diego D Araújo, PhD student, Principal investigator, State University of Montes Claros, Minas Gerais, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767258
- Sponsor's protocol ID
- EE/UFMG
- Status last verified
- Feb 2017
- First submitted
- 6 May 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.
Publications
de Araujo DD, Almeida NG, Silva PM, Ribeiro NS, Werli-Alvarenga A, Chianca TC. Prediction of risk and incidence of dry eye in critical patients. Rev Lat Am Enfermagem. 2016;24:e2689. doi: 10.1590/1518-8345.0897.2689. Epub 2016 May 17.
PubMed 27192415
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Effect of Nursing Interventions on Prevention of Dry Eye in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02767258
- Acronym / sponsor ID
- EE/UFMG
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry eye, Diseases of the eye and adnexa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Diego Dias de AraújoUniversity, hospital or other
- Collaborators
- State University of Montes Claros, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 10 May 2016 (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.
Clinical trial for prevention, randomized controlled, parallel, double-blind, with three arms, which purpose is verify the nursing interventions (artificial tear gel and liquid artificial tears)effects to prevent dry eye in adult patients admitted in ICU.
Detailed description
Critically ill patients are at higher risk for dry eye 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. Thus, the general objective of this study was to evaluate the risk for developing dry eye in critically ill patients and the effectiveness of three types of interventions: eye gel and eyedrops (control group). The specific objectives were: verify the most effective intervention for the prevention of dry eye from the available literature and provided by: eye gel compared to the control group eyedrops who received eye care through randomized controlled clinical trial. Patients and methods: This study is a randomized controlled trial to determine the best care for the prevention of dry eye from those available on the market (eye drops and eye gel), in the period from 14/01/2016 to 31/12/2019 . The expected result is: negative values in Schirmer test and no corneal ulcers presence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator: Eye drop | Active comparator | Device: LACRIBELL®Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing. |
| VIDISIC® GEL | Experimental | Device: VIDISIC® GELOcular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be over 18 years;
- Did not present dry eye at the time of admission;
- Stay in the ICU for at least 24 hours;
- Be in mechanical ventilation therapy;
- Glance less than 5 per minute;
Key exclusion criteria (2 listed)
- Have not the responsabille authorization;
- Patients with severe eye disease or with history of adverse effects after use of any of the interventions proposed and not tolerate the treatment: artificial tear gel, artificial tear liquid and saline 0.9%.
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: liquid artificial tears, eyedropHypromellose and dextran based eyedrop, used in the treatment of dry eye. | Device | Sham Comparator: Eye drop |
| VIDISIC® GELAlso: artificial tear gelCarbomer based gel, used in the treatment of dry eye. | Device | VIDISIC® GEL |
Primary outcome
Dry Eye
Time frame: Five consecutive days
Interventions will be applied in both eyes of the patients from 12 to 12 hours for five consecutive days. Schirmer test will be applyed to evaluate the lacrimal volume. Fluorescein test will be applyed to evaluate the ocular surface.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Background: PubMed 27192415de Araujo DD, Almeida NG, Silva PM, Ribeiro NS, Werli-Alvarenga A, Chianca TC. Prediction of risk and incidence of dry eye in critical patients. Rev Lat Am Enfermagem. 2016;24:e2689. doi: 10.1590/1518-8345.0897.2689. Epub 2016 May 17.
- Individual participant dataSharing planned: No. The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.
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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.
Diego D Araújo, PhD student principal investigator
State University of Montes Claros, Minas Gerais, Brazil
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® and VIDISIC® GEL in people with Dry Eye Syndromes, run by Diego Dias de Araújo 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Feb 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego D Araújo, PhD student (55 (38) 3213 2150 ext. Brazil, diego.dias1508@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry Eye (time frame: Five consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02767258, which also lists 1 linked publication.
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 14 Feb 2017.