Effect of benzalkonium chloride-free latanoprost ophthalmic solution on ocular surface in patients with glaucoma

Tejaswini Walimbe,¹ Vidya Chelerkar,² Purvi Bhagat,³ Abhijeet Joshi,⁴ Atul Raut<sup>4

1</sup>Walimbe Eye Clinic, ²PBMA's H.V. Desai Eye Hospital, Pune, ³Glaucoma Clinic, M and J Western Regional Institute of Ophthalmology, Civil Hospital, Ahmedabad, ⁴Clinical Research Department, Sun Pharma Advanced Research Company Ltd., Mumbai, India

Introduction: Benzalkonium chloride (BAK), included as a preservative in many topical treatments for glaucoma, induces significant toxicity and alters tear breakup time (TBUT). BAK-containing latanoprost, an ester prodrug of prostaglandin F_2a, can cause ocular adverse events (AEs) associated with BAK. The purpose of this study was to evaluate the efficacy and safety of BAK-free latanoprost.
Patients and methods: A prospective, open-label, single-arm, multicenter, 8-week study in patients with primary open-angle glaucoma or ocular hypertension taking BAK-containing latanoprost for ≥12 months was performed. Patients were switched to BAK-free latanoprost ophthalmic solution 0.005% administered once daily, and eyes were assessed after 28 and 56 days. Primary efficacy and safety variables were TBUT and treatment-emergent AEs, respectively.
Results: At day 56, 40 eyes were evaluable. Mean TBUT increased significantly from baseline (3.67±1.60 seconds) to 5.03±2.64 and 6.06±3.39 seconds after 28 and 56 days of treatment with BAK-free latanoprost (P<0.0001). Ocular Surface Disease Index^© (OSDI^©) score also decreased significantly to 12.06±13.40 and 7.06±10.75 at 28 and 56 days, respectively, versus baseline (18.09±18.61, P<0.0001). In addition, inferior corneal staining score decreased significantly to 0.53 from baseline (0.85, P=0.0033). A reduction in conjunctival hyperemia and intraocular pressure was observed at both time points. No treatment-related serious AEs were evident and 12 (26.08%) treatment-emergent AEs occurred in seven patients, with eye pain and irritation being the most frequent. No clinically significant changes in vital signs or slit lamp examinations were observed.
Conclusion: Results indicate that switching from BAK-containing latanoprost to BAK-free latanoprost resulted in significant improvements in TBUT, OSDI^© score, and inferior corneal staining score, and measurable reductions in conjunctival hyperemia score. Furthermore, BAK-free latanoprost was well tolerated with only mild-to-moderate and self-limiting AEs. BAK-free latanoprost appears to be effective in protecting ocular surface integrity in glaucoma patients but further studies are needed to confirm this beneficial effect.

Keywords: tear breakup time, TBUT, Ocular Surface Disease Index, OSDI^©, inferior corneal staining score, conjunctival hyperemia, intraocular pressure, glaucoma, ocular surface


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