Efficacy and safety of latanoprost versus pilocarpine/timolol maleate fixed combination in patients with primary open-angle glaucoma or ocular hypertension.
OBJECTIVE
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.
Kałuzny
Józef
J
Ophthalmology Clinic, UMK Medical College, Bydgoszcz, Poland.
Sobecki
Roman
R
Czechowicz-Janicka
Krystyna
K
Kecik
Dariusz
D
Kałuzny
Bartłomiej J
BJ
Stewart
Jeanette A
JA
Stewart
William C
WC
D000368:Aged; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005123:Eye; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000139:chemically induced; D010862:Pilocarpine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013999:Timolol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014786:Vision Disorders / Q000139:chemically induced
D004338:Drug Combinations; D011461:Prostaglandins F, Synthetic; D010862:Pilocarpine; D000077338:Latanoprost; D013999:Timolol