Ocular surface disease in patients with glaucoma or ocular hypertension treated with either BAK-preserved latanoprost or BAK-free travoprost

Abstract

Purpose: 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 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: benzalkonium chloride; glaucoma; ocular surface; preservative; prostaglandin analog.

Figure 1

Participant flow through the study. When possible, patients who discontinued treatment were analyzed before exiting the study, so discontinuation and analysis numbers are not mutually exclusive. Abbreviation: BAK, benzalkonium chloride.

Figure 2

Mean scores on the OSDI questionnaire for the patients who had mild OSD at baseline. Error bars represent standard error of the mean. *P < 0.05. In the BAK-free travoprost group, patient numbers were 141 at baseline, 135 at week 6, and 140 at week 12. In the BAK-preserved latanoprost group, patient numbers were 136 at baseline, 134 at week 6, and 132 at week 12. Abbreviations: BAK, benzalkonium chloride: OSDI, Ocular Surface Disease Index; OSD, ocular surface disease.

Figure 3

Mean change from baseline scores on the OSDI questionnaire for the patients who had mild ocular surface disease at baseline. Error bars represent standard error of the mean. Abbreviations: BAK, benzalkonium chloride; OSDI, Ocular Surface Disease Index.

Figure 4

Percentage of patients who had baseline mild-severity scores on the OSDI and who improved to normal OSDI scores. Abbreviations: BAK, benzalkonium chloride OSDI, Ocular Surface Disease Index.

Figure 5

Percentage of patients who had been exposed to BAK-preserved latanoprost for >24 months prior to entry in the study, and who improved to normal scores on the OSDI 12 weeks after switching to BAK-free travoprost. Abbreviations: BAK, benzalkonium chloride; OSDI, Ocular Surface Disease Index.