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F. Binlich, C. Baudouin, P.–J. Pisella, C. Garcher, L. Nicolas–Oprea, CatioDry Study Group; A Novel Cationic Emulsion, Cationorm®, for Treatment of Patients With Bilateral Moderate Dry Eye Syndrome . Invest. Ophthalmol. Vis. Sci. 2006;47(13):254.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the tolerance of 2 strengths of Cationorm® containing 1% and 2% of oil versus saline (NaCl) 0.9% eye drops in patients with bilateral moderate dry eye syndrome following one month of treatment. Due to its cationic charge associated with oil contained in the emulsion, Cationorm® has demonstrated optimal spreading to the eyes, thus improving lipid content of tears.
It was planned to enrol 72 patients in a phase II, multicenter, single–masked, randomized, 3 parallel groups, NaCl controlled study. Both products were administered 4 times daily during one month. Objective ocular tolerance and subjective symptoms related and unrelated to instillation were assessed.
75 patients were enrolled in the study. The 3 treatment groups were comparable with respect to baseline parameters. Results are presented in the intention to treat (ITT) population. Clinically relevant improvement of the dry eye syndrome was reported with both Cationorm ® eye drops as assessed by increases in mean Schirmer test ,mean BUT and by decreases in the mean lissamine green global score reported at the end of the study. Improvement was more marked in the Cationorm®1% treated patients. Most frequent ocular events related to instillation of Cationorm® were transient burning/stinging or blurred vision. Most of the patients considered that Cationorm® eye drops were comfortable.
Cationorm® eye drops were safe and well tolerated in patients suffering from moderate dry eye syndrome. Moreover, exploratory analysis of efficacy has shown a trend towards improvement of the dry eye syndrome that was more marked with Cationorm® 1% eye drops. Cationorm® 1% eye drops seem to be a promising local treatment for dry eye syndrome.
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