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

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 ≥19 y 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 12 wk 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 12 wk 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.

Clear lens extraction as the first line treatment of primary angle closure/primary angle closure glaucoma

Angle closure glaucoma(ACG)is one of the major causes of blindness.Angle closure occurs from the obstruction of the trabecular meshwork by the peripheral iris,which results in increased intraocular pressure(IOP)through impaired aqueous flow.Considering pupillary block by crystalline lens is the most frequent mechanism,lens extraction is regarded as an effective therapy.Recently,to validate the effect of lens extraction,the EAGLE study was reported.In this study,subjects were 50 years or older,did not have cataracts,and had newly diagnosed primary angle closure(PAC)with intraocular pressure 30 mmHg or greater or primary angle-closure glaucoma(PACG),and were divided into clear-lens extraction group and standard care group(laser peripheral iridotomy and topical glaucoma medication).This study suggested that clear-lens extraction showed greater efficacy and was more cost-effective than laser peripheral iridotomy.Initial clear lens extraction showed better clinical course and patient-reported outcomes.This study provided evidence to support clear lens extraction as the first line treatment for PAC with high IOP or PACG patients.