Efficacy and Tolerability of a New Latanoprost 0.005% BAK-Free Nanoemulsion: A Nonrandomized Open-Label Trial

Abstract

Purpose: To assess the effectiveness and tolerability of a new latanoprost 0.005% benzalkonium chloride (BAK)-free nanoemulsion. Methods: A nonrandomized multicenter study was conducted between January 2017 and October 2017 in 15 ophthalmological clinics from Argentina. This study enrolled 113 patients with primary open angle glaucoma or pseudoexfoliative glaucoma, who had been under treatment with any BAK-preserved latanoprost ophthalmic solution 0.005% as monotherapy for at least 6?months, switch to administer latanoprost BAK-free nanoemulsion. Primary outcome was intraocular pressure (IOP) lowering efficacy at 4, 8, and 12?weeks after treatment switch. Secondary outcomes included clinical signs and symptoms of ocular surface damage (Ocular Surface Disease Index (OSDI), conjunctival hyperemia, Schirmer I test, tear film break-up time (BUT), corneal epithelial fluorescein staining, and tear meniscus height). Results: In total, 103 patients (198 eyes) concluded the study. Mean IOP values between baseline and at week 12 were 14.63 (95% confidence interval (CI), 14.25 to 15.01) and 13.65 (95% CI, 13.32 to 13.98). After a 12?weeks of treatment switch, mean Ocular Surface Diseases Index score decreased by 11.53 units (95% CI, 15.18 to 7.88; p < 0.0001), and the number of eyes with conjunctival hyperemia decreased by 27.8% (95% CI, 17.93 to 37.64; p < 0.0001). Mean break-up time increased by 1.75?seconds (95% CI, 1.37 to 2.12; p < 0.0001) 12?weeks after treatment switch, and the number of eyes with corneal staining decreased by 19.7% (95% CI, 11.68 to 27.72; p < 0.0001). Conclusions: The new nanoemulsion maintains the decreasing intraocular pressure effect, with significant improvements in signs and symptoms of ocular surface disease.

Keywords

• Latanoprost
• BAK-free
• nanoemulsion
• glaucoma
• ocular surface