Background/aim - Carteolol is a adrenoceptor antagonist used topically to r
educe intraocular pressure, typically twice daily. In an effort to provide
a once daily dosing regimen, carteolol was formulated with 1% alginic acid.
The objective of this study was to evaluate the efficacy and safety of car
teolol alginate solution in comparison with standard carteolol solution.
Methods - This was a double masked, parallel group, multicentre study. Pati
ents with ocular hypertension or open angle glaucoma (n=235) were randomly
assigned to receive either carteolol alginate four times daily or standard
carteolol solution, twice daily. The masking was maintained through the use
of a vehicle in the evening for the alginate group. Patients were evaluate
d at baseline, 15, 60, and 120 days.
Results - At 0900 (presumed trough) on day 60, mean reductions in intraocul
ar pressure (IOP) from baseline were 6.09 (SD 2.97) and 6.09 (3.18) mm Hg f
or the standard carteolol and alginate, respectively. At 1100 (presumed pea
k), mean reductions were 6.51 (2.53) and 6.47 (2.76) mm Hg, respectively. R
esults were similar at other times (day 15 and day 120). The most common si
de effect was transient stinging on instillation of drops, which did not di
ffer significantly between groups. There were no differences of note in oth
er ocular or systemic signs or symptoms.
Conclusion - The new alginate formulation of carteolol 2% given once daily
was as effective as standard carteolol 2% given twice daily with no meaning
ful differences regarding safety.