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Claudine Annie Civiale, Rita Mencucci, Anja Liekfeld, Antonio Scialdone, Thomas Ach, MARIA GRAZIA MAZZONE, Aldo Caporossi; Efficacy and safety of a reduced posology of Netilmicin/Dexamethasone ophthalmic gel versus the eye drops in the treatment of inflammation conditions following cataract surgery. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1688.
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To demonstrate the twice a day (BID) efficacy and safety of Netilmicin/Dexamethasone ophthalmic hydrogel containing Xanthan gum, versus Netilmicin/Dexamethasone eye drops four times a day (QID), in the treatment of inflammatory conditions after cataract surgery in the presence or at risk of microbial infection.
Phase III international multicenter (n=5) double-blind, non-inferiority study: a total of 168 patients, male and female, aged >40 years, were randomized to receive the Netilmicin/Dexamethasone ophthalmic hydrogel BID (N=85) or the eye drops QID (N=83) from the day of phaco-emulsification cataract extraction (Day0) until Day15. To ensure double masking, the gel group received 2 doses of active treatment and 2 doses of placebo. Patients were evaluated at Screening Visit (4 to 7 days before cataract surgery), Visit 2 (Day0), Visit 3 (Day1), Visit 4 (Day7±1), Visit 5 (Day15±2) and at Visit 6 (Follow-up Day60±3). Full responders (patients with absence of cells and flare in anterior chamber) percentage were evaluated at 7 days as primary endpoint. Difference of full responder proportion was analyzed by Chi square test for proportion along with one-sided 97.5% confidence interval of the difference based on Student’s t distribution. Secondary parameters (microbial measurements, intraocular pressure, evaluation of ocular discomfort, visual acuity and safety) were evaluated at each visit.
Flare and cellularity were resolved at Day 7 post-surgery in 92.5% of patients and completely by Day 15. In both ITT (Intent to Treat) and PP (Per Protocol) populations, efficacy analysis showed that the hydrogel BID is non-inferior to the QID administered eye drops. For ITT analysis, the lower limit of the 97.5% confidence interval (-0.0580) is greater than the non-inferiority limit of -0.10. For the PP analysis the lower limit of the 97.5% confidence Interval (-0.0562) is greater than the non-inferiority limit of -0.10. For secondary parameters, no differences were observed between the two treatment groups. No microbial load and no safety issues were observed.
The current study demonstrated that hydrogel reduced posology (BID) is not inferior to the approved eye drops posology (QID) for the clinical response obtained after 7 days. Both treatments were very well tolerated and efficacious.
This is a 2020 ARVO Annual Meeting abstract.
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