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Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose
BACKGROUND: 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...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2014
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3883617/ https://www.ncbi.nlm.nih.gov/pubmed/24403819 http://dx.doi.org/10.2147/OPTH.S53822 |
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author | Cohen, Stephen Martin, Anna Sall, Kenneth |
author_facet | Cohen, Stephen Martin, Anna Sall, Kenneth |
author_sort | Cohen, Stephen |
collection | PubMed |
description | BACKGROUND: 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. |
format | Online Article Text |
id | pubmed-3883617 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-38836172014-01-08 Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose Cohen, Stephen Martin, Anna Sall, Kenneth Clin Ophthalmol Original Research BACKGROUND: 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. Dove Medical Press 2014 2013-12-31 /pmc/articles/PMC3883617/ /pubmed/24403819 http://dx.doi.org/10.2147/OPTH.S53822 Text en © 2014 Cohen et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Cohen, Stephen Martin, Anna Sall, Kenneth Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose |
title | 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_short | 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 |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3883617/ https://www.ncbi.nlm.nih.gov/pubmed/24403819 http://dx.doi.org/10.2147/OPTH.S53822 |
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