Efficacité et tolérance d’un gel de carbomère fluide versus un gel de carbomère classique lors du traitement du syndrome sec

Chiambaretta, F.; Pouliquen, P; Menerath, J.-M.; Pilotaz, Frédéric; Rebika, Hayette; Rigal, D

doi:10.1016/s0181-5512(04)96106-2

Cited by 8 publications

(3 citation statements)

References 14 publications

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“…To demonstrate the non-inferiority of Homeoptic® versus Larmabak®, a 95% bilateral confidence interval (95% CI) of the primary endpoint was calculated. Based on published data, 21 the non-inferiority threshold was set at 10 mm. If the upper bound of the 95% CI was less than 10 mm, non-inferiority was demonstrated at a unilateral α/2 risk of 2.5%.…”

Section: Methodsmentioning

confidence: 99%

Homoeopathic eye drops in the treatment of mild-to-moderate dry eye disease: Randomised, prospective, multicentre, single-masked study

Mortemousque,

Pisella,

Salaun

et al. 2023

European Journal of Ophthalmology

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Introduction To compare the efficacy and safety of a homeopathic eye drop medicinal product (Homeoptic®) with 0.9% sodium hydrochloride eye drops (Larmabak®) in patients with mild-to-moderate dry eye disease (DED). Methods Prospective, single-masked, observer-blinded, multicentre study on adult patients. Non-inferiority primary endpoint of the relative change between treatment groups in a composite Visual Analogue Scale (VAS) score covering five symptoms of DED, namely pain, itching, sensation of dry eye, impression of foreign body presence and burning, after 30 days of treatment. Details of all Adverse Events (AEs) were recorded and analysed. Results Ninety three patients were randomised to each treatment arm. At Day 30, the mean VAS symptom score was 26.0 ± 18.8 in the Homeoptic® group and 32.8 ± 21.2 Larmabak® group. Homeoptic® was demonstrated to be non-inferior to Larmabak®: the mean treatment difference of −7 being below the 10 mm upper limit of the 95% CI ([-12.9; −1.0]) pre-set as significant. The superiority of Homeoptic® over Larmabak® was then established with detection of a significant difference between the two treatment groups (p = 0.022). Significant differences between the treatment groups in favour of Homeoptic® were also detected in isolated VAS scores for the symptoms dry eye sensation ( p = 0.009) and burning ( p = 0.004). Results of ocular surface staining tests to estimate corneal and conjunctival damage as well as patient satisfaction were also significantly in favour of Homeoptic®. No new safety concerns were identified. Conclusion Homeoptic® is more effective than Larmabak® at relieving the symptoms of DED and constitutes an effective treatment for mild-to-moderate DED.

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Section: Methodsmentioning

confidence: 99%

Homoeopathic eye drops in the treatment of mild-to-moderate dry eye disease: Randomised, prospective, multicentre, single-masked study

Mortemousque,

Pisella,

Salaun

et al. 2023

European Journal of Ophthalmology

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“…One study simply indicated the use of Ôartificial tearsÕ (Tsifetaki et al, 2003) and this could indicate either that traditional products were used or that a range of different and unspecified products were actually used; the former perspective was taken for these analyses. A total of seven data sets were identified with suitable information on the use of some type of carbomer (polyacrylic acid)-based formulation (Laroche et al, 1991;Lepri et al, 1991;Sullivan et al, 1997;Troiano et al, 1997;Chiambaretta et al, 2004;Ostuni et al, 2005). Finally, 10 sets of data were found on the use of hyaluronate-based polymer formulations.…”

Section: Overall Summary Of Data Setsmentioning

confidence: 99%

Efficacy of different dry eye treatments with artificial tears or ocular lubricants: a systematic review

Doughty

Glavin

2009

Ophthalmic Physiologic Optic

123

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Purpose: To objectively review the outcome of clinical studies where rose bengal stain (RB) has been used as an outcome measure to assess the efficacy of artificial tears (AT) in patients with dry eye. Methods: From peer-reviewed articles published between 1947 and 2008, information was sought on dry eye status, as reported using a grading scheme, after use of RB as a diagnostic test, before and after use of a specific regimen of artificial tears or ocular lubricants for approximately 30 days. Mean baseline scores and post-treatment scores were calculated, along with the net change and the percentage change in the RB scores. Results: From a total of 33 suitable data sets, published between 1985 and 2006, the group mean pre-treatment RB score was 4.25 ± 1.55 (±S.D.), which decreased to 2.84 ± 1.24 after 30 days of treatment. This represented a net change of )1.43 (95% CI of )1.04 to )1.45). For use of traditional AT (saline, hypromellose, etc), the net change was )0.95, it was )1.33 for use of carbomer (polyacrylic acid) gels and )2.10 for hyaluronic acid (HA) products. These changes represented net improvements of 25.9 ± 18.4%, 38.0 ± 20.7% and 41.8 ± 16.3% respectively. The greater change with HA was not associated with a lower final outcome score, but with higher pretreatment scores. Conclusions: Based on RB grading schemes used by numerous different clinicians over many years, treatment of dry eye with artificial tears or ocular lubricants can be expected to improve the condition of the exposed ocular surface. Assuming no improvement without treatment, a 30 days treatment period can be projected to produce an overall improvement of around 25%, but with no unambiguous statistical differences between product types.

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“…In 2013, another latanoprost formulation was approved. This solution without BAK contains a non-ionic surfactant [macrogolglycerol hydroxystearate 40 at 5% (MGHS 40)] with a combination of thickening agents (Carbomer 974P and Macrogol 4000) susceptible to increase stability and residence time on the ocular surface [ 14 ]. Recently, a new preservative-free (PF) latanoprost formulation without surfactant (SF) nor thickening agents (PF SF latanoprost) was also approved in several European countries.…”

Section: Introductionmentioning

confidence: 99%

Comparison of In Vitro Corneal Permeation and In Vivo Ocular Bioavailability in Rabbits of Three Marketed Latanoprost Formulations

Chauchat,

Guerin,

Kaluzhny

et al. 2023

Eur J Drug Metab Pharmacokinet

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Background and Objective All latanoprost formulations currently available for the treatment of glaucoma or ocular hypertension contain the same concentration of latanoprost (0.005%) but differ in excipients, which may affect corneal drug permeability or stability. This study aimed at comparing corneal penetration of three marketed latanoprost solutions with different excipient formulations in in vitro and in vivo drug permeability studies. Methods Three latanoprost formulations were tested under good laboratory practice conditions: a formulation containing benzalkonium chloride (BAK) but no surfactant (Preserved latanoprost); the same formulation except preservative-free (PF) without BAK or surfactant (SF) (PF SF latanoprost); and a different formulation without BAK but containing a non-ionic surfactant (MGHS 40 at 5%) combined with thickening agents (Carbomer 974P, Macrogol 4000) (PF latanoprost). Corneal permeation of latanoprost acid (LAT) was first determined in vitro using a reconstructed human corneal epithelium tissue. Then, in vivo pharmacokinetic studies were performed on pigmented rabbits, for which LAT concentration was measured in the aqueous humour (AH) and iris–ciliary body (ICB). Results In vitro , the cumulative transport of LAT was linear between 1 h and 4 h for preserved latanoprost and PF SF latanoprost, and LAT concentrations matched exactly at each timepoint. By contrast, the permeation of PF latanoprost was linear between 2 h and 12 h and was significantly lower than that of preserved latanoprost and PF SF latanoprost at 4 and 8 h ( p < 0.001). In rabbits, the concentrations of LAT in AH and ICB were not statistically different between preserved latanoprost and PF SF latanoprost at each timepoint, except at 1 h in ICB ( p = 0.005). By comparison, the LAT concentration of PF latanoprost was statistically ( p < 0.05) lower than that of preserved latanoprost and PF SF latanoprost in AH and ICB from 0.5 to 3 h. Conclusion BAK did not influence the corneal penetration of latanoprost in in vitro and in vivo studies. The formulation containing a non-ionic surfactant resulted in lower and slower ocular penetration compared with preserved or PF SF formulations. This raises questions about the relevance of BAK and some surfactants in enhancing corneal penetration of ocular formulations.

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Efficacité et tolérance d’un gel de carbomère fluide versus un gel de carbomère classique lors du traitement du syndrome sec

Cited by 8 publications

References 14 publications

Homoeopathic eye drops in the treatment of mild-to-moderate dry eye disease: Randomised, prospective, multicentre, single-masked study

Homoeopathic eye drops in the treatment of mild-to-moderate dry eye disease: Randomised, prospective, multicentre, single-masked study

Efficacy of different dry eye treatments with artificial tears or ocular lubricants: a systematic review

Comparison of In Vitro Corneal Permeation and In Vivo Ocular Bioavailability in Rabbits of Three Marketed Latanoprost Formulations

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