Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose

Stephen Cohen,1 Anna Martin,2 Kenneth Sall31Cohen Optometry, Scottsdale, AZ, USA; 2Alcon Laboratories Inc, Fort Worth, TX, USA; 3Sall Research Medical Center Inc, Artesia, CA, USABackground: The purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks...

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Autores principales:	Cohen S, Martin A, Sall K
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/94f5d24bed744a88ac1cfa7374434480
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spelling	oai:doaj.org-article:94f5d24bed744a88ac1cfa73744344802021-12-02T03:43:57ZEvaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose1177-5483https://doaj.org/article/94f5d24bed744a88ac1cfa73744344802013-12-01T00:00:00Zhttp://www.dovepress.com/evaluation-of-clinical-outcomes-in-patients-with-dry-eye-disease-using-a15410https://doaj.org/toc/1177-5483 Stephen Cohen,1 Anna Martin,2 Kenneth Sall31Cohen Optometry, Scottsdale, AZ, USA; 2Alcon Laboratories Inc, Fort Worth, TX, USA; 3Sall Research Medical Center Inc, Artesia, CA, USABackground: The purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks of treatment with Systane® Gel Drops or Refresh Liquigel® lubricant eye drops.Methods: Patients aged ≥18 years with a sodium fluorescein corneal staining sum score of ≥3 in either eye and best-corrected visual acuity of 0.6 logarithm of the minimum angle of resolution or better in each eye who were using a lubricant eye gel or ointment for dry eye were included in this randomized, parallel-group, multicenter, double-blind trial. Patients were randomized to four times daily Systane® Gel Drops (polyethylene glycol 400 0.4% and propylene glycol 0.3%) or Refresh LiquiGel® Drops (carboxymethylcellulose sodium 1%) for 6 weeks. The primary efficacy outcome was mean change from baseline to week 6 in sodium fluorescein corneal staining. Supportive efficacy outcomes included conjunctival staining, tear film break-up time, Patient Global Assessment of Improvement, Impact of Dry Eye on Everyday Life (IDEEL) Treatment Satisfaction/Treatment Bother Questionnaire, Single Symptom Comfort Scale, and Ocular Symptoms Questionnaire. The safety analysis comprised recording of adverse events.Results: In total, 147 patients (Systane group, n=73; Refresh group, n=74; mean ± standard deviation age, 57±16 years) were enrolled and included in the safety and efficacy analyses. Corneal staining was significantly reduced from baseline to week 6 for Systane and Refresh (−3.4±2.5 and −2.5±2.6 units, respectively; P<0.0001, t-test), with a significantly greater improvement with Systane versus Refresh (P=0.0294). Results for conjunctival staining, tear film break-up time, and patient-reported outcome questionnaires were not statistically different between groups. No safety issues were identified; adverse events were reported by 19% of patients with Systane and 30% of patients with Refresh eye drops.Conclusion: Systane Gel Drops were associated with significantly better corneal staining scores versus Refresh Liquigel eye drops in patients with dry eye. Supportive efficacy outcomes were not significantly different between groups. Both treatments were well tolerated.Keywords: artificial tears, corneal staining, Systane Gel Drops, Refresh Liquigel, patient-reported outcomesCohen SMartin ASall KDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2014, Iss default, Pp 157-164 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Cohen S Martin A Sall K Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
description	Stephen Cohen,1 Anna Martin,2 Kenneth Sall31Cohen Optometry, Scottsdale, AZ, USA; 2Alcon Laboratories Inc, Fort Worth, TX, USA; 3Sall Research Medical Center Inc, Artesia, CA, USABackground: The purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks of treatment with Systane® Gel Drops or Refresh Liquigel® lubricant eye drops.Methods: Patients aged ≥18 years with a sodium fluorescein corneal staining sum score of ≥3 in either eye and best-corrected visual acuity of 0.6 logarithm of the minimum angle of resolution or better in each eye who were using a lubricant eye gel or ointment for dry eye were included in this randomized, parallel-group, multicenter, double-blind trial. Patients were randomized to four times daily Systane® Gel Drops (polyethylene glycol 400 0.4% and propylene glycol 0.3%) or Refresh LiquiGel® Drops (carboxymethylcellulose sodium 1%) for 6 weeks. The primary efficacy outcome was mean change from baseline to week 6 in sodium fluorescein corneal staining. Supportive efficacy outcomes included conjunctival staining, tear film break-up time, Patient Global Assessment of Improvement, Impact of Dry Eye on Everyday Life (IDEEL) Treatment Satisfaction/Treatment Bother Questionnaire, Single Symptom Comfort Scale, and Ocular Symptoms Questionnaire. The safety analysis comprised recording of adverse events.Results: In total, 147 patients (Systane group, n=73; Refresh group, n=74; mean ± standard deviation age, 57±16 years) were enrolled and included in the safety and efficacy analyses. Corneal staining was significantly reduced from baseline to week 6 for Systane and Refresh (−3.4±2.5 and −2.5±2.6 units, respectively; P<0.0001, t-test), with a significantly greater improvement with Systane versus Refresh (P=0.0294). Results for conjunctival staining, tear film break-up time, and patient-reported outcome questionnaires were not statistically different between groups. No safety issues were identified; adverse events were reported by 19% of patients with Systane and 30% of patients with Refresh eye drops.Conclusion: Systane Gel Drops were associated with significantly better corneal staining scores versus Refresh Liquigel eye drops in patients with dry eye. Supportive efficacy outcomes were not significantly different between groups. Both treatments were well tolerated.Keywords: artificial tears, corneal staining, Systane Gel Drops, Refresh Liquigel, patient-reported outcomes
format	article
author	Cohen S Martin A Sall K
author_facet	Cohen S Martin A Sall K
author_sort	Cohen S
title	Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
title_short	Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
title_full	Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
title_fullStr	Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
title_full_unstemmed	Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
title_sort	evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/94f5d24bed744a88ac1cfa7374434480
work_keys_str_mv	AT cohens evaluationofclinicaloutcomesinpatientswithdryeyediseaseusinglubricanteyedropscontainingpolyethyleneglycolorcarboxymethylcellulose AT martina evaluationofclinicaloutcomesinpatientswithdryeyediseaseusinglubricanteyedropscontainingpolyethyleneglycolorcarboxymethylcellulose AT sallk evaluationofclinicaloutcomesinpatientswithdryeyediseaseusinglubricanteyedropscontainingpolyethyleneglycolorcarboxymethylcellulose
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Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose

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