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Trial record 15 of 32 for:    PANTHENOL

Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches (OCUREA2)

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ClinicalTrials.gov Identifier: NCT02348242
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.

This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.


Condition or disease Intervention/treatment Phase
Corneal Diseases Device: Aqueous Gel Device: Eyelid Occlusion Dressing Device: Artificial Tears Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study
Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aqueous gel
In the same patient : one eye receives regular administration of aqueous gel (experimental treatment 1) and the other eye receives regular administration of artificial tears (active comparator)
Device: Aqueous Gel
1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours
Other Name: Dexpanthenol® 0.2%

Device: Artificial Tears
1 drop of Phylarm® artificial tears in the eye every 6 hours
Other Name: Phylarm®

Experimental: Eyelid occlusion dressing
In the same patient : one eye is closed with an eyelid closure dressing (experimental treatment 2) and the other eye receives regular administration of artificial tears (active comparator)
Device: Eyelid Occlusion Dressing
Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily
Other Name: Pro-Ophta® Dressing

Device: Artificial Tears
1 drop of Phylarm® artificial tears in the eye every 6 hours
Other Name: Phylarm®




Primary Outcome Measures :
  1. Incidence rate of corneal lesions (grade > 0 in the Mercieca classification) [ Time Frame: participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult patient
  • hospitalized in an intensive care unit
  • tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h

Exclusion Criteria:

  • Patient currently treated by eyedrops for glaucoma
  • antecedent of corneal transplant
  • ocular prosthesis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348242


Locations
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France
Fondation ophtalmologique Adolphe de Rothschild
Paris, Ile-de-France, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Jean-Michel DEVYS, Dr Fondation Ophtalomologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02348242     History of Changes
Other Study ID Numbers: 2014-A01197-40
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Intensive care
corneal damage
prevention
nursing protocol
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions