Purchase this article with an account.
P. Goldschmidt, P.–P. Elena, H. Baldwin, L. Delval, J. Colin; Efficacy and Safety of Diclofenac 0.1% ABAK® versus preserved Diclofenac ® 0.1% Eye Drops in Controlling Post–Cataract Surgery Inflammation. . Invest. Ophthalmol. Vis. Sci. 2004;45(13):294.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose: To compare the efficacy and safety of diclofenac sodium 0.1% eye drops in ABAK® multi–dose container without preservative (ABAK) and sodium merthiolate–preserved diclofenac 0.1% eye drops (Voltarène®) in controlling post–cataract surgery inflammation. Methods: In this randomized, single–masked, active–controlled, parallel–group, multicenter, non–inferiority study, 194 patients undergoing phacoemulsification were randomly treated with either ABAK (n = 96) or preserved diclofenac (n = 98) instilled 2 X before, 1 X during, and 2 X after surgery on D0, then TID for 28 days. No steroids were allowed. Ocular inflammation was measured by biomicroscopy on D1, D3, D7 and D28, overall assessment by the investigator of anti–inflammatory response on D28, best corrected visual acuity on D7 and D28 and failure rate. The primary efficacy criterion was the total score for anterior chamber cells and flare on D7. Non–inferiority was defined as the average/median score in the ABAK group not exceeding the average/median score in the control group by 0.5 points on D7. Safety and local tolerance were evaluated. Results: Total scores of cells and flare on D7 were 0.25 ± 0.54 (SD), 0.0 (median) in the ABAK group and 0.39 ± 0.91, 0.0 in the unpreserved diclofenac group. ABAK was shown to be non inferior to unpreserved diclofenac. The investigator assessed the efficacy as satisfactory for 98.7% in the ABAK group (95.1% for control group). One discontinuation for treatment failure was noted in the ABAK group, and 3 in unpreserved diclofenac group. Both treatments were well tolerated after 28 days: less than 5% of patients in each treatment group had clinically relevant corneal fluorescein–stained punctuations at any study visit. There were no notable differences in terms of adverse event. Conclusions: Diclofenac 0.1% ABAK® and preserved diclofenac are effective in controlling post–cataract surgery inflammation in absence of combination with steroids. The preservative–free formulation of Diclofenac 0.1% ABAK® does not modify the potent anti–inflammatory effect of diclofenac and shows a good safety profile after TID treatment for 1 month.
This PDF is available to Subscribers Only