Efficacy assessment of Nutrilarm®, a per os omega-3 and omega-6 polyunsaturated essential fatty acid dietary formulation versus placebo in patients with bilateral treated moderate dry eye syndrome
Copyright © 2011. Published by Elsevier Masson SAS..
INTRODUCTION: Inflammation is one of the main mechanisms common to all forms of dry eye. Since polyunsaturated acids are known to show biological anti-inflammatory properties, the aim of this study was to evaluate the efficacy of dietary n-6 and n-3 fatty acids in patients suffering from ocular dryness.
PATIENTS AND METHODS: One hundred and eighty-one patients diagnosed with bilateral moderate dry eye who were already treated with lachrymal substitutes were randomized in a double-blind international study to receive placebo or Nutrilarm(®) capsules (combination of omega-3 and omega-6), twice a day for 6 months. In all subjects, dryness feeling, overall subjective comfort, and ocular symptoms (burning, stinging, sandy and/or gritty sensation, light sensitivity, reflex tearing, and ocular fatigue) were evaluated at each visit. Furthermore, fluorescein tests (break-uptime and Oxford scheme) and lissamine green test were performed at each visit. The Schirmer test was performed at inclusion and after 6 months of treatment.
RESULTS: After 6 months of supplementation with Nutrilarm(®), both the BUT scores and ocular fatigue were significantly improved when compared with placebo (P=0.036 and P=0.044, respectively). There was a trend in favor of Nutrilarm(®) in terms of the efficacy evaluated by the investigator (P=0.061). Fewer patients experienced a feeling of severe dryness with Nutrilarm(®) compared with placebo after 6 months of treatment (2.5 and 9.3%, respectively), but the difference was not statistically significant.
CONCLUSION: Oral administration of a double supplementation dietary n-6 and n-3 fatty acids present an additional therapeutic advantage in patients suffering from ocular dryness who were already treated with lachrymal substitutes.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2011 |
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| Erschienen: |
2011 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:34 |
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| Enthalten in: |
Journal francais d'ophtalmologie - 34(2011), 7 vom: 01. Sept., Seite 448-55 |
| Sprache: |
Französisch |
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| Weiterer Titel: |
Évaluation de l'efficacité du Nutrilarm®, complément nutritionnel à base d'acides gras essentiels polyinsaturés oméga 3 et oméga 6, versus placebo chez des patients atteints de sécheresse oculaire bilatérale modérée et traitée |
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| Beteiligte Personen: |
Creuzot-Garcher, C [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial, Phase III |
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| Anmerkungen: |
Date Completed 24.01.2012 Date Revised 12.09.2011 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jfo.2011.01.018 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM209393645 |
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| 245 | 1 | 0 | |a Efficacy assessment of Nutrilarm®, a per os omega-3 and omega-6 polyunsaturated essential fatty acid dietary formulation versus placebo in patients with bilateral treated moderate dry eye syndrome |
| 246 | 3 | 3 | |a Évaluation de l'efficacité du Nutrilarm®, complément nutritionnel à base d'acides gras essentiels polyinsaturés oméga 3 et oméga 6, versus placebo chez des patients atteints de sécheresse oculaire bilatérale modérée et traitée |
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| 500 | |a Date Completed 24.01.2012 | ||
| 500 | |a Date Revised 12.09.2011 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2011. Published by Elsevier Masson SAS. | ||
| 520 | |a INTRODUCTION: Inflammation is one of the main mechanisms common to all forms of dry eye. Since polyunsaturated acids are known to show biological anti-inflammatory properties, the aim of this study was to evaluate the efficacy of dietary n-6 and n-3 fatty acids in patients suffering from ocular dryness | ||
| 520 | |a PATIENTS AND METHODS: One hundred and eighty-one patients diagnosed with bilateral moderate dry eye who were already treated with lachrymal substitutes were randomized in a double-blind international study to receive placebo or Nutrilarm(®) capsules (combination of omega-3 and omega-6), twice a day for 6 months. In all subjects, dryness feeling, overall subjective comfort, and ocular symptoms (burning, stinging, sandy and/or gritty sensation, light sensitivity, reflex tearing, and ocular fatigue) were evaluated at each visit. Furthermore, fluorescein tests (break-uptime and Oxford scheme) and lissamine green test were performed at each visit. The Schirmer test was performed at inclusion and after 6 months of treatment | ||
| 520 | |a RESULTS: After 6 months of supplementation with Nutrilarm(®), both the BUT scores and ocular fatigue were significantly improved when compared with placebo (P=0.036 and P=0.044, respectively). There was a trend in favor of Nutrilarm(®) in terms of the efficacy evaluated by the investigator (P=0.061). Fewer patients experienced a feeling of severe dryness with Nutrilarm(®) compared with placebo after 6 months of treatment (2.5 and 9.3%, respectively), but the difference was not statistically significant | ||
| 520 | |a CONCLUSION: Oral administration of a double supplementation dietary n-6 and n-3 fatty acids present an additional therapeutic advantage in patients suffering from ocular dryness who were already treated with lachrymal substitutes | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a English Abstract | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Fatty Acids, Omega-3 |2 NLM | |
| 650 | 7 | |a Fatty Acids, Omega-6 |2 NLM | |
| 650 | 7 | |a Nutrilarm |2 NLM | |
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| 700 | 1 | |a Labetoulle, M |e verfasserin |4 aut | |
| 700 | 1 | |a Pisella, P-J |e verfasserin |4 aut | |
| 700 | 1 | |a Mouriaux, F |e verfasserin |4 aut | |
| 700 | 1 | |a Meddeb-Ouertani, A |e verfasserin |4 aut | |
| 700 | 1 | |a El Matri, L |e verfasserin |4 aut | |
| 700 | 1 | |a Khairallah, M |e verfasserin |4 aut | |
| 700 | 1 | |a Brignole-Baudouin, F |e verfasserin |4 aut | |
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