A Comprehensive Review of the Clinical Evidence Comparing Benzalkonium Chloride–Preserved and Benzalkonium Chloride–Free Latanoprost in the Treatment of Primary Open-Angle Glaucoma and Ocular Hypertension

Harsh Kumar,1 Rajul Parikh,2 Amyn Chagani,3 KomelAbbas G Bhojani,4 Prachi Jain,5 Shruti Dharmadhikari,5 Chaitanya Bhargave,5 Amey Mane,5 Suyog Mehta5 1Glaucoma Services, Centre for Sight, New Delhi, India; 2Department of Ophthalmology, Shreeji Eye Institute and Research Centre, Palak’s Glaucoma Care Centre, Mumbai, Maharashtra, India; 3Department of Ophthalmology, Chagani Eye and Dental Care, Mumbai, Maharashtra, India; 4Medical Affairs and Clinical Research, Sun Pharmaceutical Industries Limited, Mumbai, Maharashtra, India; 5Medical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, Maharashtra, IndiaCorrespondence: KomelAbbas G Bhojani, Medical Affairs and Clinical Research, Sun Pharmaceutical Industries Limited, Mumbai, Maharashtra, India, Email [email protected]: This review aims to consolidate and evaluate the clinical evidence on the efficacy and safety of benzalkonium chloride (BAK)-preserved and BAK-free latanoprost in the treatment of primary open-angle glaucoma (POAG) and ocular hypertension (OHT). The primary research question addresses whether BAK-free formulations offer comparable efficacy with improved safety profiles compared to BAK-preserved formulations.Methods: An extensive literature search was conducted using PubMed up to February 2025. Keywords included “latanoprost”, “primary open-angle glaucoma”, “ocular hypertension”, “efficacy”, and “safety”. Inclusion criteria were peer-reviewed clinical trials and meta-analyses comparing latanoprost with placebo or other treatments (eg. bimatoprost, travoprost, tafluprost, latanoprostene bunod). Exclusion criteria included observational studies, review articles, and studies comparing preservative-free prostaglandin analogues and omidenepag.Results: Thirty-two studies (17 randomized clinical trials and 7 meta-analyses) were reviewed. Latanoprost, the first FDA-approved prostaglandin analogue, primarily increases uveoscleral outflow. Comparative studies indicate that latanoprost achieves a good balance between IOP reduction and tolerability compared to bimatoprost, travoprost, tafluprost, and unoprostone. Latanoprost also reduces visual field progression and maintains central corneal thickness (CCT). It improves ocular perfusion pressure (OPP), reducing the risk of glaucomatous optic neuropathy. Safety profiles show fewer side effects, such as conjunctival hyperemia, hypertrichosis, and periocular pigmentation, compared to other PGAs. BAK-free formulations demonstrate improved corneal health and patient compliance due to reduced ocular surface toxicity.Conclusion: Latanoprost remains a first-line therapy for POAG and OHT due to its efficacy, safety, and patient adherence. The availability of BAK-free formulations enhances its therapeutic profile, with reduced corneal toxicity making it a preferred choice for long-term glaucoma management.Keywords: latanoprost, BAK- free, primary open-angle glaucoma, ocular hypertension, benzalkonium chloride, intraocular pressure, prostaglandin analogues, efficacy, safety