Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye

Alejandro J Aguilar, Maria I Marquez, Paula A Albera, Jorge L Tredicce, Alejandro Berra Universidad de Buenos Aires, Buenos Aires, Argentina Purpose: To evaluate the ability of Systane® Balance (SYSB) administered four times per day for 4 weeks to increase noninvasive tear film break-up t...

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Autores principales: Aguilar AJ, Marquez MI, Albera P, Tredicce JL, Berra A
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Publicado: Dove Medical Press 2014
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spelling oai:doaj.org-article:02f0c0bccbba429f804b73cc59a6cd6c2021-12-02T06:12:03ZEffects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye1177-5483https://doaj.org/article/02f0c0bccbba429f804b73cc59a6cd6c2014-11-01T00:00:00Zhttp://www.dovepress.com/effects-of-systanereg-balance-on-noninvasive-tear-film-break-up-time-i-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483 Alejandro J Aguilar, Maria I Marquez, Paula A Albera, Jorge L Tredicce, Alejandro Berra Universidad de Buenos Aires, Buenos Aires, Argentina Purpose: To evaluate the ability of Systane® Balance (SYSB) administered four times per day for 4 weeks to increase noninvasive tear film break-up time (NITFBUT) over baseline compared with a saline (SAL) control in patients with lipid-deficient dry eye (DE).Patients and methods: Patients aged ≥18 years with DE and evidence of meibomian gland dysfunction (ie, abnormal gland expression and missing meibomian glands) were included in this randomized, parallel-group, controlled, investigator-masked comparison study. Patients were randomized to SYSB or SAL four times daily for 4 weeks. The primary efficacy variable was mean change in NITFBUT from baseline at week 4. Ocular surface staining, goblet cell density, and meibomian gland expression were also assessed. Safety assessments included adverse events (AEs), best-corrected visual acuity, and ocular signs.Results: A total of 49 patients received study treatments (SYSB, n=25; SAL, n=24). Most patients were women (67.4%) and Caucasian (63.3%); mean ± standard deviation (SD) age was 44±19 years. DE characteristics at baseline were similar between groups. After 4 weeks of treatment, the mean ± SD NITFBUT increase from baseline was significantly greater with SYSB (2.83±0.74 seconds) compared with SAL (0.66±0.55 seconds; P<0.001, t-test). Improvements in conjunctival and corneal staining, percentage of patients with increased goblet cell density, and meibomian gland expression were also observed with 4 weeks of SYSB over SAL. No AEs were reported for either treatment group; best-corrected visual acuity and ocular signs remained stable or improved compared with baseline.Conclusion: SYSB restored tear film stability, improved ocular surface healing, and improved meibomian gland functionality after 4 weeks of use in patients with lipid-deficient DE. No AEs were reported with either SYSB or SAL. Keywords: artificial tears, corneal staining, conjunctival staining, goblet cellsAguilar AJMarquez MIAlbera PTredicce JLBerra ADove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2014, Iss default, Pp 2365-2372 (2014)
institution DOAJ
collection DOAJ
language EN
topic Ophthalmology
RE1-994
spellingShingle Ophthalmology
RE1-994
Aguilar AJ
Marquez MI
Albera P
Tredicce JL
Berra A
Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye
description Alejandro J Aguilar, Maria I Marquez, Paula A Albera, Jorge L Tredicce, Alejandro Berra Universidad de Buenos Aires, Buenos Aires, Argentina Purpose: To evaluate the ability of Systane® Balance (SYSB) administered four times per day for 4 weeks to increase noninvasive tear film break-up time (NITFBUT) over baseline compared with a saline (SAL) control in patients with lipid-deficient dry eye (DE).Patients and methods: Patients aged ≥18 years with DE and evidence of meibomian gland dysfunction (ie, abnormal gland expression and missing meibomian glands) were included in this randomized, parallel-group, controlled, investigator-masked comparison study. Patients were randomized to SYSB or SAL four times daily for 4 weeks. The primary efficacy variable was mean change in NITFBUT from baseline at week 4. Ocular surface staining, goblet cell density, and meibomian gland expression were also assessed. Safety assessments included adverse events (AEs), best-corrected visual acuity, and ocular signs.Results: A total of 49 patients received study treatments (SYSB, n=25; SAL, n=24). Most patients were women (67.4%) and Caucasian (63.3%); mean ± standard deviation (SD) age was 44±19 years. DE characteristics at baseline were similar between groups. After 4 weeks of treatment, the mean ± SD NITFBUT increase from baseline was significantly greater with SYSB (2.83±0.74 seconds) compared with SAL (0.66±0.55 seconds; P<0.001, t-test). Improvements in conjunctival and corneal staining, percentage of patients with increased goblet cell density, and meibomian gland expression were also observed with 4 weeks of SYSB over SAL. No AEs were reported for either treatment group; best-corrected visual acuity and ocular signs remained stable or improved compared with baseline.Conclusion: SYSB restored tear film stability, improved ocular surface healing, and improved meibomian gland functionality after 4 weeks of use in patients with lipid-deficient DE. No AEs were reported with either SYSB or SAL. Keywords: artificial tears, corneal staining, conjunctival staining, goblet cells
format article
author Aguilar AJ
Marquez MI
Albera P
Tredicce JL
Berra A
author_facet Aguilar AJ
Marquez MI
Albera P
Tredicce JL
Berra A
author_sort Aguilar AJ
title Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye
title_short Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye
title_full Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye
title_fullStr Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye
title_full_unstemmed Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye
title_sort effects of systane® balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye
publisher Dove Medical Press
publishDate 2014
url https://doaj.org/article/02f0c0bccbba429f804b73cc59a6cd6c
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