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Clinical Trial
. 2004 Jul;88(7):877-83.
doi: 10.1136/bjo.2003.029330.

A comparison of the fixed combination of latanoprost and timolol with the unfixed combination of brimonidine and timolol in patients with elevated intraocular pressure. A six month, evaluator masked, multicentre study in Europe

J García-Sánchez  1 , J-F Rouland, D Spiegel, B Pajic, I Cunliffe, C Traverso, J Landry
Affiliations
Clinical Trial

A comparison of the fixed combination of latanoprost and timolol with the unfixed combination of brimonidine and timolol in patients with elevated intraocular pressure. A six month, evaluator masked, multicentre study in Europe

J García-Sánchez et al. Br J Ophthalmol. 2004 Jul.

Abstract

Purpose: To compare the intraocular pressure (IOP) reducing effect and safety of fixed combination (FC) latanoprost/timolol with unfixed combination (UFC) brimonidine/timolol in patients with increased IOP.

Methods: In this 6 month, randomised, evaluator masked, parallel group European study, patients with glaucoma or ocular hypertension and IOP > or =21 mm Hg on monotherapy or >16 mm Hg on dual therapy received either FC latanoprost/timolol at 8:00AM or UFC brimonidine/timolol at 8:00AM and 8:00PM. The primary outcome was the difference from baseline to month 6 in mean diurnal IOP reduction.

Results: 325 of 334 randomised patients were included in intent to treat analyses (FC latanoprost/timolol, 163; UFC brimonidine/timolol, 162). Baseline diurnal IOP levels were similar: FC latanoprost/timolol, 26.4 (SD 2.7) mm Hg; UFC brimonidine/timolol, 26.5 (SD 2.8) mm Hg (p = 0.851). At month 6, levels were 16.9 (SD 2.8) mm Hg in FC latanoprost/timolol patients and 18.2 (SD 3.1) mm Hg in UFC brimonidine/timolol patients (p<0.001). No adverse events were reported by 76.4% and 75.5% of patients receiving FC latanoprost/timolol versus UFC brimonidine/timolol, respectively. Larger proportions of brimonidine/timolol treated patients reported study medication related adverse events (18.6% v 7.3%) and discontinued study participation because of this (10.8% v 1.8%).

Conclusion: Fixed combination latanoprost/timolol administered once daily is both more effective and better tolerated than twice daily dosing with UFC brimonidine/timolol.

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Figures

Figure 1
Figure 1
Unadjusted mean diurnal intraocular pressure (IOP) levels by treatment and visit intent to treat population. *p = 0.001, †p<0.001, t tests for difference between groups in mean IOP changes from baseline. SEM, standard error of the mean.
Figure 2
Figure 2
Percentages of patients reaching specified intraocular pressure (IOP) levels (intent to treat population).
See this image and copyright information in PMC

References

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