Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye
Juan Francisco Llamas-Moreno,1 Leopoldo Martín Baiza-Durán,1 Laura Ray Saucedo-Rodríguez,2 José Félix Alaníz-De la O21Clinical Research Department, Laboratorios Sophia, SA de CV Zapopan, Jalisco, México; 2Ophthalmology Depa...
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Dove Medical Press
2013
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oai:doaj.org-article:cc0d57ffcfa74593a2cbcfe127e0f4282021-12-02T00:53:15ZEfficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye1177-54671177-5483https://doaj.org/article/cc0d57ffcfa74593a2cbcfe127e0f4282013-05-01T00:00:00Zhttp://www.dovepress.com/efficacy-and-safety-of-chondroitin-sulfatexanthan-gum-versus-polyethyl-a13188https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Juan Francisco Llamas-Moreno,1 Leopoldo Martín Baiza-Durán,1 Laura Ray Saucedo-Rodríguez,2 José Félix Alaníz-De la O21Clinical Research Department, Laboratorios Sophia, SA de CV Zapopan, Jalisco, México; 2Ophthalmology Department, Fray Antonio Alcalde Hospital, Guadalajara, Jalisco, MéxicoPurpose: To evaluate the efficacy and safety of two ophthalmic solutions in patients with mild to moderate dry eye.Methods: We performed a prospective, 2-month-long, randomized, double-blind, single-center, parallel clinical trial to compare the efficacy and safety of two ophthalmic solutions for dry eye treatment. Patients were randomly assigned to one of the two treatment groups, study group or active-control group, and received one drop four times a day. The primary efficacy endpoint was to extend the tear film break-up time (TBUT) after 2 months of treatment. The Ocular Surface Disease Index (OSDI) was also evaluated. Safety measures were assessed by the presence of adverse events.Results: A total of 28 patients with mild to moderate dry eye were included in the per protocol analysis. TBUT was similar between groups at baseline (chondroitin sulfate and xanthan gum [CS/XG] group, 5.2 ± 2.3; Systane® group, 4.7 ± 2.6; P = 0.488), after 2 months of treatment, TBUT was still similar in both groups (CS/XG group, 6.1 ± 2.5; Systane® group, 7.3 ± 2.5; P = 0.088). Baseline OSDI was similar between the groups (CS/XG group, 18.8 ± 5.3; Systane® group, 19.8 ± 7.1; P = 0.810), but after 2 months of treatment, the OSDI was significantly lower in the CS/XG group (6.7 ± 5.7 versus 10.8 ± 6.4; P = 0.049). An adverse event was present in the CS/XG group, but it was not related to the treatment.Conclusions: In this population of patients with mild to moderate dry eye, treatment with CS/XG was as effective as treatment with Systane® with regard to TBUT; nevertheless, treatment in the CS/XG group was more effective at diminishing OSDI.Keywords: dry eye, efficacy, safety, TBUT, OSDILlamas-Moreno JFBaiza-Durán LMSaucedo-Rodríguez LRAlaníz-De la O JFDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2013, Iss default, Pp 995-999 (2013) |
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Ophthalmology RE1-994 Llamas-Moreno JF Baiza-Durán LM Saucedo-Rodríguez LR Alaníz-De la O JF Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye |
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Juan Francisco Llamas-Moreno,1 Leopoldo Martín Baiza-Durán,1 Laura Ray Saucedo-Rodríguez,2 José Félix Alaníz-De la O21Clinical Research Department, Laboratorios Sophia, SA de CV Zapopan, Jalisco, México; 2Ophthalmology Department, Fray Antonio Alcalde Hospital, Guadalajara, Jalisco, MéxicoPurpose: To evaluate the efficacy and safety of two ophthalmic solutions in patients with mild to moderate dry eye.Methods: We performed a prospective, 2-month-long, randomized, double-blind, single-center, parallel clinical trial to compare the efficacy and safety of two ophthalmic solutions for dry eye treatment. Patients were randomly assigned to one of the two treatment groups, study group or active-control group, and received one drop four times a day. The primary efficacy endpoint was to extend the tear film break-up time (TBUT) after 2 months of treatment. The Ocular Surface Disease Index (OSDI) was also evaluated. Safety measures were assessed by the presence of adverse events.Results: A total of 28 patients with mild to moderate dry eye were included in the per protocol analysis. TBUT was similar between groups at baseline (chondroitin sulfate and xanthan gum [CS/XG] group, 5.2 ± 2.3; Systane® group, 4.7 ± 2.6; P = 0.488), after 2 months of treatment, TBUT was still similar in both groups (CS/XG group, 6.1 ± 2.5; Systane® group, 7.3 ± 2.5; P = 0.088). Baseline OSDI was similar between the groups (CS/XG group, 18.8 ± 5.3; Systane® group, 19.8 ± 7.1; P = 0.810), but after 2 months of treatment, the OSDI was significantly lower in the CS/XG group (6.7 ± 5.7 versus 10.8 ± 6.4; P = 0.049). An adverse event was present in the CS/XG group, but it was not related to the treatment.Conclusions: In this population of patients with mild to moderate dry eye, treatment with CS/XG was as effective as treatment with Systane® with regard to TBUT; nevertheless, treatment in the CS/XG group was more effective at diminishing OSDI.Keywords: dry eye, efficacy, safety, TBUT, OSDI |
format |
article |
author |
Llamas-Moreno JF Baiza-Durán LM Saucedo-Rodríguez LR Alaníz-De la O JF |
author_facet |
Llamas-Moreno JF Baiza-Durán LM Saucedo-Rodríguez LR Alaníz-De la O JF |
author_sort |
Llamas-Moreno JF |
title |
Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye |
title_short |
Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye |
title_full |
Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye |
title_fullStr |
Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye |
title_full_unstemmed |
Efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye |
title_sort |
efficacy and safety of chondroitin sulfate/xanthan gum versus polyethylene glycol/propylene glycol/hydroxypropyl guar in patients with dry eye |
publisher |
Dove Medical Press |
publishDate |
2013 |
url |
https://doaj.org/article/cc0d57ffcfa74593a2cbcfe127e0f428 |
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