An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye

George Ousler III,1 Douglas K Devries,2 Paul M Karpecki,3 Joseph B Ciolino41Ora, Inc, Andover, MA, USA; 2Eye Care Associates of Nevada, Sparks, NV, USA; 3Koffler Vision Group, Lexington, KY, USA; 4Massachusetts Eye and Ear, Boston, MA, USAAbstract: A single-center, open-label study consisting of tw...

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Autores principales: Ousler III G, Devries DK, Karpecki PM, Ciolino JB
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Publicado: Dove Medical Press 2015
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spelling oai:doaj.org-article:4db31c4f1c954fa3a7bda2b553b972362021-12-02T04:34:08ZAn evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye1177-5483https://doaj.org/article/4db31c4f1c954fa3a7bda2b553b972362015-02-01T00:00:00Zhttp://www.dovepress.com/an-evaluation-of-retainetrade-ophthalmic-emulsion-in-the-management-of-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483 George Ousler III,1 Douglas K Devries,2 Paul M Karpecki,3 Joseph B Ciolino41Ora, Inc, Andover, MA, USA; 2Eye Care Associates of Nevada, Sparks, NV, USA; 3Koffler Vision Group, Lexington, KY, USA; 4Massachusetts Eye and Ear, Boston, MA, USAAbstract: A single-center, open-label study consisting of two visits over the course of approximately 2 weeks was conducted to evaluate the efficacy of Retaine™ ophthalmic emulsion in improving the signs and symptoms of dry eye. Forty-two subjects were enrolled and received 1–2 drops twice daily of Retaine™ beginning at the first visit (day 1) and ending at the second visit. Subjects were instructed to complete a symptomatology diary twice daily prior to drop instillation through the morning of the second visit. Ocular sign and symptom assessments, visual acuity procedures, and comfort assessments were conducted during both visits. A statistically significant reduction was observed in mean breakup area on the second visit between the predose time and the postdose time (P=0.026). On the second visit, subjects had significantly less corneal fluorescein staining in the superior (P=0.002), central (P=0.017), corneal sum (P=0.011), and all ocular regions combined (P=0.038) than on the first visit. On the second visit, statistically significant reductions in dryness (P<0.001), grittiness (P=0.0217), ocular discomfort (P=0.0017), and all symptoms (P<0.001) were also seen as measured by the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire (0–5 scale). Subjects reported a statistically significant improvement in their abilities to work with a computer at night (P=0.044). Mean drop comfort scores ranged from 1.29–1.81 on the Ora Calibra™ 0–10 Drop Comfort Scale, on which 0 is very comfortable and 10 is very uncomfortable. Retaine™ demonstrates promising results as a novel artificial tear option for individuals suffering from dry eye. The unique mechanism of action of Retaine™ provides enhanced comfort and improves the quality of life of dry eye subjects while reducing the ocular signs of dry eye.Keywords: artificial tears, dry eye syndrome, quality of life, cationic, lipid emulsion, mean breakup areaOusler III GDevries DKKarpecki PMCiolino JBDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2015, Iss default, Pp 235-243 (2015)
institution DOAJ
collection DOAJ
language EN
topic Ophthalmology
RE1-994
spellingShingle Ophthalmology
RE1-994
Ousler III G
Devries DK
Karpecki PM
Ciolino JB
An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye
description George Ousler III,1 Douglas K Devries,2 Paul M Karpecki,3 Joseph B Ciolino41Ora, Inc, Andover, MA, USA; 2Eye Care Associates of Nevada, Sparks, NV, USA; 3Koffler Vision Group, Lexington, KY, USA; 4Massachusetts Eye and Ear, Boston, MA, USAAbstract: A single-center, open-label study consisting of two visits over the course of approximately 2 weeks was conducted to evaluate the efficacy of Retaine™ ophthalmic emulsion in improving the signs and symptoms of dry eye. Forty-two subjects were enrolled and received 1–2 drops twice daily of Retaine™ beginning at the first visit (day 1) and ending at the second visit. Subjects were instructed to complete a symptomatology diary twice daily prior to drop instillation through the morning of the second visit. Ocular sign and symptom assessments, visual acuity procedures, and comfort assessments were conducted during both visits. A statistically significant reduction was observed in mean breakup area on the second visit between the predose time and the postdose time (P=0.026). On the second visit, subjects had significantly less corneal fluorescein staining in the superior (P=0.002), central (P=0.017), corneal sum (P=0.011), and all ocular regions combined (P=0.038) than on the first visit. On the second visit, statistically significant reductions in dryness (P<0.001), grittiness (P=0.0217), ocular discomfort (P=0.0017), and all symptoms (P<0.001) were also seen as measured by the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire (0–5 scale). Subjects reported a statistically significant improvement in their abilities to work with a computer at night (P=0.044). Mean drop comfort scores ranged from 1.29–1.81 on the Ora Calibra™ 0–10 Drop Comfort Scale, on which 0 is very comfortable and 10 is very uncomfortable. Retaine™ demonstrates promising results as a novel artificial tear option for individuals suffering from dry eye. The unique mechanism of action of Retaine™ provides enhanced comfort and improves the quality of life of dry eye subjects while reducing the ocular signs of dry eye.Keywords: artificial tears, dry eye syndrome, quality of life, cationic, lipid emulsion, mean breakup area
format article
author Ousler III G
Devries DK
Karpecki PM
Ciolino JB
author_facet Ousler III G
Devries DK
Karpecki PM
Ciolino JB
author_sort Ousler III G
title An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye
title_short An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye
title_full An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye
title_fullStr An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye
title_full_unstemmed An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye
title_sort evaluation of retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye
publisher Dove Medical Press
publishDate 2015
url https://doaj.org/article/4db31c4f1c954fa3a7bda2b553b97236
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