Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial

Abstract

BackgroundDry eye disease (DED) is multifactorial, affecting 5–34 % of the global adult population and reducing quality of life. The artificial tears or lubricants are the therapy most used for the treatment of DED, due to their low side effect profile, which attempt to modify the properties of the tear film. The aim of the present study was to evaluate the clinical efficacy of a fixed combination of xanthan gum and chondroitin sulfate preservative free on the ocular surface of patients with dry eye disease during 60 days of intervention.MethodsA phase III, double-blind, masked, controlled, multicenter, clinical trial of 148 subjects, randomized to either a fixed combination of xanthan gum 0.09 % and chondroitin sulfate 0.1 % (XG/CS) ophthalmic solution (n = 76) or a fixed combination of polyethylene glycol 400 0.4 % and propylene glycol 0.3 % (PEG/PG) (n = 72). Subjects self-dosed four times daily during 60 days. Follow-up was set on days 2, 7, 15, 30 and 60. Assessments of anterior/posterior segment ocular signs were performed. The outcome measures included Schirmer test, tear film break-up time and OSDI score. Security variables included intraocular pressure, lisamine green and fluorescein ocular surface stains.ResultsThe primary efficacy endpoints were similar between groups at baseline. After intervention time Schirmer test increased in both groups compared to baseline, XG/CS (6.4 ± 2.2 vs 11.0 ± 6.6; p = 0.002) and PEG/PG (6.5 ± 2.5 vs 10.5 ± 5.6; p = 0.019) respectively. Similar results were reported in the tear film break-up time in XG/CS (5.5 ± 2.1 vs 7.4 ± 2.9; p = 0.027) and PEG/PG (5.2 ± 2.0 vs 7.4 ± 2.7; p = 0.046) respectively. The OSDI score decreased to normal values in both groups, XG/CS (19.3 ± 7.4 vs 7.3 ± 5.9; p = 0.001) and PEG/PG (19.3 ± 7.5 vs 7.9 ± 8.2; p = 0.001) respectively. There was no significant difference between treatments for any parameter. Moreover, both groups decreased the presence of burning sensation, tearing, foreign body sensation, conjunctival hyperemia and photophobia. The adverse events were not related to the interventions.ConclusionsXanthan gum/chondroitin sulfate preservative free showed similar clinical efficacy, evaluated with OSDI score, TBUT and Schirmer test compared to polyethylene glycol/propylene glycol in the treatment of dry eye disease.Trial registrationClinicalTrials.gov: NCT01657253. Date of registration May 19, 2014.

Heterologous production of chondroitin

“…Depending on their application, different systems have been implemented for the administration of chondroitin and its derivatives, including oral administration as food additives, in pharmaceutical preparations, nutraceuticals or veterinary supplements [ 74 , 75 , 76 , 77 ]; incorporation in intra-articular or intravenous injectables [78] ; integration in skin dermatology/cosmeceutical and ophthalmic products [ 79 , 80 , 81 ]; as part of medical devices [ 82 , 83 , 84 , 85 ]; or as biomaterials for regenerative medicine [ 9 , 86 ].…”

“…In these studies, CS has shown to be safe and, generally, exhibited slight to moderate efficacy over placebo in pain relief and function improvement in osteoarthritis patients. Also, CS is included in eye drop solutions for dry eyes [ 79 , 80 ]. Preservative-free ophthalmic solutions combining xanthan gum and CS or combining sodium HA and CS showed similar efficacy compared to polyethylene glycol and propylene glycol solutions in the treatment of dry eye disease.…”

Oxidized chondroitin sulfate eye drops ameliorate the prognosis of fungal keratitis with anti-inflammatory and antifungal effects

“…13 Previous investigations have revealed that CS exerts multiple biological effects and pharmacological activities, such as promoting cell regeneration, 14 anti-inflammation, 15 and antioxidation 16 and has been clinically used for osteoarthritis [17][18][19] and dry eye treatment. 20,21 The anti-inflammatory property is one of the most important biological activities of CS. 22,23 Our previous study showed that CS ameliorated the prognosis of FK by inhibiting the recruitment of neutrophils and alleviating the inflammatory response by downregulating the TLR-4/nuclear factor-k-gene binding (NF-kB) pathway.…”

Efficacy and Safety of Sodium Hyaluronate/chondroitin Sulfate Preservative-free Ophthalmic Solution in the Treatment of Dry Eye: A Clinical Trial

“…There are many different formulations of ocular lubricants such as those containing sodium hyaluronate, cellulose-based derivatives, hypo-osmolar formulations, lipid-based emulsions, glycerincontaining drops, polysaccharides, and polyethylene glycol/ propylene glycol (PEG/PG) with HP-guar. 9,10 Systane® Ultra and Systane® Ultra preservative-free (Alcon Research. Ltd., Fort Worth, Texas, USA) are artificial tears containing PEG and PG with demonstrated efficacy in the management of DED.…”