An interventional study of LACRIBELL® and VIDISIC® GEL in Dry Eye Syndromes, sponsored by Diego Dias de Araújo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-14.
Sponsored by Diego Dias de Araújo · Not applicable, Interventional, and Prevention
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.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Diego Dias de Araújo as lead sponsor.
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Exclusion Criteria:
Eye drop LACRIBELL® - two drops each eye, two times a day, after eye cleansing.
Device: LACRIBELL®
Ocular gel VIDISIC® GEL applied two times a day at the lower palpebra from medium line to the lateral border.
Device: VIDISIC® GEL
Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
Also known as: liquid artificial tears, eyedrop
Carbomer based gel, used in the treatment of dry eye.
Also known as: artificial tear gel
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.
Time frame: Five consecutive days
Plan to share: 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.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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