Efficacy and safety of latanoprost versus pilocarpine/timolol maleate fixed combination in patients with primary open‐angle glaucoma or ocular hypertension

PURPOSE: This study aimed to compare the safety and effect on intraocular pressure (IOP) of latanoprost given every evening versus pilocarpine/timolol maleate fixed combination (PTFC) given twice daily in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH). METHODS: Following a 6-week, medicine-free period, qualified patients were randomized for Period 1 to either placebo administered every morning and latanoprost every evening or to PTFC administered twice daily. After 8 weeks of treatment, IOP was measured at 08.00, 10.00, 16.00 and 18.00 hours. Patients were then switched to the opposite treatment and underwent a second diurnal evaluation at the end of Period 2. RESULTS: Thirty-two patients completed this study. They demonstrated diurnal baseline IOP of 24.1 +/- 2.4 mmHg. Mean diurnal pressure was 16.8 +/- 2.1 mmHg on PTFC and 16.9 +/- 2.5 mmHg on latanoprost (p = 0.60). No statistical difference between treatments was observed at any individual time-point except at 10.00 hours, when the PTFC group demonstrated an IOP of 15.9 +/- 2.3 mmHg and latanoprost 16.8 +/- 2.7 mmHg (p = 0.02). There were no statistical differences between groups in unsolicited systemic or ocular adverse events (p > 0.05). However, the PTFC group showed a narrower pupil diameter (2.3 mm) than the latanoprost group (3.7 mm). Additionally, a solicited symptom survey demonstrated mild blurred vision, stinging and ocular pain with PTFC (p < 0.001). CONCLUSIONS: Both PTFC and latanoprost are efficacious in reducing diurnal IOP in POAG or OH. However, PTFC may be more effective in the late morning and may have a greater incidence of mild ocular side-effects.