Ocular hypotensive efficacy and safety of once daily carteolol alginate.
OBJECTIVE
Carteolol is a beta adrenoceptor antagonist used topically to reduce 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 carteolol alginate solution in comparison with standard carteolol solution.


METHODS
This was a double masked, parallel group, multicentre study. Patients with ocular hypertension or open angle glaucoma (n=235) were randomly assigned to receive either carteolol alginate once daily [corrected] 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 evaluated at baseline, 15, 60, and 120 days.


RESULTS
At 0900 (presumed trough) on day 60, mean reductions in intraocular pressure (IOP) from baseline were 6.09 (SD 2.97) and 6.09 (3.18) mm Hg for the standard carteolol and alginate, respectively. At 1100 (presumed peak), mean reductions were 6.51 (2.53) and 6.47 (2.76) mm Hg, respectively. Results were similar at other times (day 15 and day 120). The most common side effect was transient stinging on instillation of drops, which did not differ significantly between groups. There were no differences of note in other ocular or systemic signs or symptoms.


CONCLUSIONS
The new alginate formulation of carteolol 2% given once daily was as effective as standard carteolol 2% given twice daily with no meaningful differences regarding safety.
Demailly
P
P
Hôpital St Joseph, Institut du Glaucome, Paris, France.
Allaire
C
C
Trinquand
C
C
D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000464:Alginates / Q000737:chemistry; D000704:Analysis of Variance; D002354:Carteolol / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D020723:Glucuronic Acid; D006603:Hexuronic Acids; D006801:Humans; D007322:Instillation, Drug; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects; D014794:Visual Fields / Q000187:drug effects
D000319:Adrenergic beta-Antagonists; D000464:Alginates; D006603:Hexuronic Acids; D020723:Glucuronic Acid; D002354:Carteolol