| Past Issue | Volume 9, Number 1, February 2007 | | Post-marketing Surveillance of the Safety, Tolerability, and Efficacy of Latanoprost (XalatanTM) for Primary Open Angle Glaucoma and Ocular Hypertension |
Norman A Aquino,1 Joan Catherine P Manalo2
1American Eye Center, Mandaluyong City, and 2Pfizer Philippines Inc, Makati City, The Philippines
Aim: This non-interventional, open-label, multicentre, post-marketing surveillance study was conducted to evaluate the overall safety, tolerability, and efficacy of latanoprost (XalatanTM) for the treatment of Filipino patients with glaucoma and/or intraocular hypertension.
Methods: Patients were Filipinos with unilateral or bilateral open angle glaucoma. 721 patients were recruited and assessed, 425 of whom had elevated intraocular pressure or ocular hypertension of ≥22 mm Hg. Each patient was carefully instructed to instil one drop of latanoprost in the affected eye(s) once daily as prescribed in the product insert. If more than one topical ophthalmic drug was being used, the drugs were administered at least 5 minutes apart. Patients received latanoprost for 4 weeks and were assessed weekly during this period.
Results: Most patients (91.7%) responded to latanoprost treatment. A reduction in intraocular pressure of ≥30% occurred in 62.1% of patients. The overall mean percentage reduction in intraocular pressure at the end of the study was 40.8%. A statistically significant reduction in intraocular pressure was sustained throughout the treatment period. The results of this study compared favourably with those of previous clinical trials performed under more rigorous conditions. Side effects were reported for 47 patients, and were mainly conjunctival redness/hyperaemia. No systemic or serious adverse events were reported.
Conclusion: The study has shown that latanoprost given once daily has significant and sustained ocular hypotensive efficacy and is relatively safe for use by patients with open angle glaucoma and/or ocular hypertension.
Key words: Clinical trials, Latanoprost, Ocular hypertension, Open angle glaucoma, Treatment outcome
Asian J Ophthalmol. 2007;9:8-12.
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