Ocular surface assessment of preserved and preservative‐free brimonidine tartrate in glaucoma patients: A parallel‐grouped comparison trial

Abstract

AbstractPurpose: To evaluate and compare the efficacy and safety of preservative‐free and preserved brimonidine tartrate 0.15% in open‐angle glaucoma and ocular hypertension.Methods: We conducted a multicenter (four institutions), randomized, investigator‐masked, parallel‐group clinical trial. A total of 60 eyes of 60 patients with intraocular pressure (IOP) ≥ 15 mmHg diagnosed with open‐angle glaucoma or ocular hypertension were randomized to preserved (n = 31) and preservative‐free (n = 29) brimonidine groups. Enrolled eyes received three times daily monotherapy of brimonidine. Main outcome measures were corneal/conjunctival staining score, ocular surface disease index, patient satisfaction score, drug tolerance, and drug adherence rate at 12 weeks after the first administration. Secondary outcome measurements included visual acuity, IOP, drug tolerance, tear‐film break‐up time, hemodynamic changes including blood pressure and heart rates, and ocular adverse events.Results: After 12 weeks, both preserved and preservative‐free groups showed similar amount of IOP reduction, corneal and conjunctival staining score, drug tolerance, and adherence rate. The preservative‐free group showed significantly better TBUT and higher patient satisfaction with regard to drug use and management. The reduction amount of systolic and diastolic blood pressures during 12 weeks were significantly lower in the preserved group than the preservative‐free group.Conclusions: Preservative‐free brimonidine tartrate showed comparable efficacy and safety with better corneal tear film stability and patient satisfaction compared to preserved brimonidine.