Abstract
Purpose: :
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.
Methods: :
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.
Results: :
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.
Conclusions: :
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.
Keywords: cornea: epithelium • cornea: clinical science