Gregory Katz1, Clark L Springs2, E Randy Craven3, Michela Chairs Montecchi-Palmer41Huron Ophthalmology, Ypsilanti, MI, USA; 2Indiana University Eye Care, Indianapolis, IN, USA; 3Specialty Eye Care, Denver, CO, USA; 4Alcon Research Ltd., Fort Worth, TX, USAPurpose: The preservative benzalkonium chloride (BAK) may adversely affect ocular surface health.This study evaluated symptoms of ocular surface disease (OSD) in patients previously treated with a BAK-preserved therapy to lower their intraocular pressure, who either continued that therapy or switched to a BAK-free therapy.
Methods: Eligible adult patients with ocular hypertension or open-angle glaucoma that had been controlled with BAK-preserved latanoprost 0.005% monotherapy (Xalatan®) for at least one month and had a score of ≥ 13 (0 = none, 100 = most severe) on the Ocular Surface Disease Index (OSDI) questionnaire were entered into this prospective, double-masked, randomized, active-controlled, multicenter trial.By random assignment, patients either continued with BAK-preserved latanoprost 0.
005% or transitioned to BAK-free travoprost 0.004% (Travatan Z® ophthalmic solution).OSDI scores were assessed again after six and 12 weeks.
Results: For the 678 evaluable patients, mean change in OSDI score from baseline to week 12 favored the travoprost 0.004% BAK-free group, but was not statistically different between groups (P = 0.10).
When patients with mild OSD at baseline were assessed after 12 weeks, the mean OSDI score was significantly lower (P = 0.04) in the BAK-free travoprost 0.004% group (score = 11.
6 ± 10.8 units) than in the BAK-preserved latanoprost 0.005% group (score = 14.
4 ± 11.9 units), and a significantly larger percentage (P < 0.01) improved to normal OSDI scores in the BAK-free travoprost 0.
004% group (62.9% of group) than in the BAK-preserved latanoprost 0.005% group (47.
0% of group).Patients pretreated with BAK-preserved latanoprost 0.005% for >24 months were significantly more likely (P = 0.
03) to improve to a normal OSDI score Culinary Baskets after 12 weeks if they were switched to BAK-free travoprost 0.004% (47.9% of group) than if they remained on BAK-preserved latanoprost 0.
005% (33.9% of group).Conclusions: Switching from BAK-preserved latanoprost 0.
005% to BAK-free travoprost 0.004% yielded significant improvements in symptoms of OSD in patients with glaucoma or ocular hypertension.Keywords: ocular surface, glaucoma, benzalkonium chloride, prostaglandin analog, preservative.