Abstract
PURPOSE: To evaluate the long-term safety of latanoprost benzalkonium chloride (BAK)-free vs currently marketed latanoprost 0.005% ophthalmic solution containing BAK (referred to as reference), to treat open-angle glaucoma (OAG) or ocular hypertension (OHT). PATIENTS AND METHODS: This phase 3, multicenter, open-label, nonrandomized, single group assignment, safety study included patients who previously completed a phase 3 noninferiority study. Patients self-administered 1 drop of latanoprost BAK-free nightly for 36 weeks in the affected eye(s). Intraocular pressure (IOP), visual acuity (VA), and slit lamp biomicroscopy were assessed predose at baseline and Days 28, 56, 84, 112, 140, and 168; dilated ophthalmoscopy and visual field (VF) at baseline and Day 168. Adverse events (AEs) were recorded throughout the study. RESULTS: A total of 161 patients who previously received latanoprost BAK-free (n = 80) or reference (n = 81) were enrolled. Latanoprost BAK-free maintained lowered IOP for both the study and nonstudy eye in all patients relative to baseline throughout the study. Clinically significant retinal or optic nerve changes were identified in 5 patients (1 mild-to-moderate change, prior latanoprost BAK-free; 4 mild changes, prior reference). No clinically important changes were identified for VA, slit lamp biomicroscopy, and VF measurements. Ocular AEs occurred in 66 (82.5%) vs 74 (91.4%) patients on prior latanoprost BAK-free and reference, respectively; the most frequent being eye pain (50.0% vs 64.2%) and ocular hyperemia (47.5% vs 54.3%). Most AEs were mild. There were 5 serious systemic AEs in 5 patients (n = 3, prior latanoprost BAK-free; n = 2, prior reference); all were considered unrelated or not likely related to treatment. One patient (prior reference) discontinued due to follicular conjunctivitis. There were no deaths or serious ocular AEs. CONCLUSION: Latanoprost BAK-free was well tolerated. These findings support the chronic use of latanoprost BAK-free to treat OAG or OHT. CLINICAL TRIAL REGISTRATION NUMBER: NCT00945958.