Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial
| Autor: | Louis B. Cantor, Eleonora Safyan, Amy L. Batoosingh, Ching Chi Liu |
|---|---|
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Intraocular pressure genetic structures Glaucoma Ocular hypertension Drug Administration Schedule law.invention Randomized controlled trial Brimonidine Tartrate Double-Blind Method law Ophthalmology Quinoxalines medicine Alphagan P Humans Brimonidine Purite Antihypertensive Agents Intraocular Pressure Aged Aged 80 and over business.industry Brimonidine General Medicine Middle Aged medicine.disease eye diseases Treatment Outcome Female Ocular Hypertension sense organs business medicine.drug |
| Zdroj: | Current medical research and opinion. 24(7) |
| ISSN: | 1473-4877 |
| Popis: | To compare the safety and intraocular pressure (IOP)-lowering effects of brimonidine-purite 0.1% with the marketed formulation of brimonidine-purite 0.15% (Alphagan P 0.15%) when used twice daily (BID) by patients with glaucoma or ocular hypertension previously treated with brimonidine-purite 0.15% for at least 6 weeks.In a 12-month, randomized, double-masked, multicenter, parallel group, non-inferiority study, patients with glaucoma or ocular hypertension who were treated with brimonidine-purite 0.15% BID were randomly assigned to continue brimonidine-purite 0.15% (n=102) or to administer brimonidine-purite 0.1% (n=105) BID for 12 months. IOP was measured at approximately 8 a.m. (hour 0) and 10 a.m. (hour 2).Mean change from baseline IOP and adverse events.Demographics and baseline characteristics were similar between treatment groups. Treated-baseline mean IOPs at both timepoints were similar between groups (por = 0.606). Brimonidine-purite 0.1% provided IOP-lowering that was non-inferior to brimonidine-purite 0.15% at each of the 12 follow-up timepoints, and there were no statistically significant between-group differences at any timepoint. The most commonly reported adverse event was conjunctival hyperemia (13.5% for brimonidine-purite 0.1%; 10.8% for brimonidine-purite 0.15%). No significant differences in the incidence of adverse events were noted between the two formulations.Brimonidine-purite 0.1% BID is as effective as brimonidine-purite 0.15% BID in lowering IOP in patients with glaucoma or ocular hypertension who were previously treated with brimonidine-purite 0.15%, and both formulations are well tolerated. Limitations of the study include enrollment of only patients who were already on treatment with brimonidine-purite 0.15%. The 0.1% formulation of brimonidine-purite allows for decreased exposure to brimonidine while providing an IOP-lowering effect comparable to that of the 0.15% formulation. Clinical trial registered at clinicaltrials.gov; identifier: NCT00168363. |
| Databáze: | OpenAIRE |
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