Efficacy and safety of newly developed preservative-free latanoprost 0.005% eye drops versus preserved latanoprost 0.005% in open angle glaucoma and ocular hypertension: 12-week results of a randomized, multicenter, controlled phase III trial

Abstract

AIM: To evaluate the therapeutic efficacy, safety and tolerability of newly developed preservative-free (PF) latanoprost generic [TJO-002] and compare it with benzalkonium chloride (BAK)-preserved latanoprost [Xalatan®] in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). METHODS: Included patients were aged ≥19y with POAG/OHT. After a washout period, patients with IOP 21-35 mm Hg at 9 a.m. were enrolled. After a full ophthalmic and glaucoma examination, 144 patients with POAG and OHT participated in this study. Subjects were randomly assigned either PF latanoprost (74 eyes) or BAK-preserved latanoprost (70 eyes). All subjects were examined at 4, 8, and 12wk after first administration. At each follow-up visit, IOP was measured at 9 a.m. and 5 p.m. and compliance was assessed. Throughout the study, all adverse events were recorded and monitored by the masked investigators who measured IOP. RESULTS: Both groups showed a statistically significant decrease of average diurnal IOP at 12wk compared to baseline (-7.21±3.10 mm Hg in the PF latanoprost group and -7.02±3.17 mm Hg in the BAK latanoprost group, both P<0.0001). There was no statistically significant diurnal IOP variation between the groups. In terms of tolerability, pruritus, burning/stinging, and sticky eye sensation, severity was significantly lower in the PF latanoprost group than in the BAK latanoprost group (P<0.05). CONCLUSION: PF latanoprost has at least similar efficacy in terms of IOP reduction and better tolerability compared with BAK latanoprost.

Elevation of Tear MMP-9 Concentration as a Biomarker of Inflammation in Ocular Pathology by Antibody Microarray Immunodetection Assays

“…Prostaglandin acts by lowering intraocular pressure (IOP), the major risk factor for glaucoma [ 51 ]. Nevertheless, even though both preservative-free eye drops and BAK-preserved prostaglandin analogues showed a decrease in IOP [ 54 ], many studies have confirmed the toxicity of using BAK preservatives, which lead to destabilization of the precorneal tear film, disrupting the mucin layer and increasing tear osmolarity, which provokes DE and ocular surface disease (OSD) progression [ 55 , 56 , 57 , 58 ].…”

New Glaucoma Medications

“…Preservative-free latanoprost achieves significant decreases in average diurnal IOP and is noninferior to BAK-preserved latanoprost when used in POAG and ocular hypertension 36–39 . It has been shown to induce less corneal epithelial toxicity compared with BAK-preserved formulations 40 .…”

“…It has been shown to induce less corneal epithelial toxicity compared with BAK-preserved formulations 40 . Studies have found that patients who switched from BAK-preserved latanoprost to preservative-free latanoprost had improved satisfaction; lower rates of conjunctival hyperemia, itching, burning, and stinging; and less need for the use of lubricating artificial tears 36–39,41,42 . Switching from BAK-preserved latanoprost to a preservative-free formulation may result in reduced anterior chamber flare 43 .…”

“…Preservative-free latanoprost achieves significant decreases in average diurnal IOP and is noninferior to BAK-preserved latanoprost when used in POAG and ocular hypertension. [36][37][38][39] It has been shown to induce less corneal epithelial toxicity compared with BAK-preserved formulations. 40 Studies have found that patients who switched from BAK-preserved latanoprost to preservative-free latanoprost had improved satisfaction; lower rates of conjunctival hyperemia, itching, burning, and stinging; and less need for the use of lubricating artificial tears.…”

“…40 Studies have found that patients who switched from BAK-preserved latanoprost to preservative-free latanoprost had improved satisfaction; lower rates of conjunctival hyperemia, itching, burning, and stinging; and less need for the use of lubricating artificial tears. [36][37][38][39]41,42 Switching from BAK-preserved latanoprost to a preservative-free formulation may result in reduced anterior chamber flare. 43 Because of the improved tolerability, preservative-free latanoprost can result in improved patient adherence.…”