PURPOSE:

To evaluate the intraocular pressure (IOP)-reducing effect of the fixed combination of 0.005% latanoprost and 0.5% timolol compared with the individual monotherapies.

METHODS:

A 6-month, randomised, double-masked, controlled multicentre study followed by 6 months of open-label treatment was carried out in patients with glaucoma or ocular hypertension with pre-enrolment IOP >/=25 mmHg on glaucoma medication or >/=30 mmHg if untreated. Following a 2- to 4-week run-in period on timolol twice daily, 436 patients were randomised: 140 to fixed combination therapy once daily in the morning, 147 to latanoprost once daily in the morning and 149 to timolol twice daily. During the open-label extension, patients received fixed combination drug once daily in the morning.

RESULTS:

The difference in mean change from baseline in diurnal IOP from week 2 to week 26 was -1.2 mmHg between fixed combination and latanoprost (95% confidence interval. CI: -1.8 to -0.5; P<0.001; repeated-measures analysis of covariance). The corresponding difference between fixed combination and timolol was -1.9 mmHg (95% CI -2.5 to -1.2; P<0.001). No long-term drift in IOP was detected in patients treated for 12 months with fixed combination. All treatments were well tolerated with no major differences among groups in the incidence of clinically relevant adverse events.

CONCLUSION:

The fixed combination of 0.005% latanoprost and 0.5% timolol administered once daily in the morning for 6 months was more effective in reducing IOP than the individual components alone and was effective over 12 months.