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L.-J. Hwang, G. W. Bean, J. M. Fain, M. B. Sultan, E. Kim, J. Grunden, C. S. Tressler; The Incidence of Punctate Epithelial Erosions (PEE) in Double-Masked, Prospective, Controlled Trials of Latanoprost versus Timolol. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1218. doi: https://doi.org/.
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To determine whether doubling the amount of benzalkonium chloride (BAK) in latanoprost-treated patients was associated with an increased incidence of PEE in trials comparing latanoprost and timolol in patients with glaucoma or ocular hypertension.
A meta-analysis of the double-masked phases of 6 prospective, controlled clinical trials compared the incidence of PEE among glaucoma or ocular hypertension patients assigned to treatment with latanoprost or timolol. Timolol maleate (0.01% BAK) was given twice daily and latanoprost (0.02% BAK) was given once daily with vehicle (0.01% or 0.02% BAK) given once daily in 5 of the 6 trials; 1 study dosed both drugs once daily. All patients reporting PEE either as a finding or an adverse event were included in the analysis.
Of the 1658 patients enrolled in the double-masked portion of the trials (latanoprost, n=874; timolol, n=784), the overall incidence of PEE was 6.4%. The incidence in latanoprost-treated patients was 6.6% and was 6.1% in those treated with timolol. The combined risk difference of latanoprost - timolol was 0.008 (95% CI: -0.015, 0.031; P=0.495), and the combined odds ratio of latanoprost versus timolol for PEE was 1.114 (95% CI: 0.726, 1.710; P=0.620). The amount of the preservative BAK was approximately twice as great in the latanoprost arm compared to the timolol arm.
The incidence of PEE was similar and not statistically significantly different between latanoprost- and timolol-treated patients. Doubling the amount of BAK in the latanoprost arm was not associated with an increased incidence of PEE.
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