Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: A 12-month randomized trial

Louis Cantor, Eleonora Safyan, Ching Chi Liu, Amy L. Batoosingh

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objective: 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. Methods: 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). Main outcome measures: Mean change from baseline IOP and adverse events. Results: Demographics and baseline characteristics were similar between treatment groups. Treated-baseline mean IOPs at both timepoints were similar between groups (p ≥ 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)2035-2043
Number of pages9
JournalCurrent Medical Research and Opinion
Volume24
Issue number7
DOIs
StatePublished - Jul 2008

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Ocular Hypertension
compound A 12
Glaucoma
Intraocular Pressure
Brimonidine Tartrate
Hyperemia

Keywords

  • Brimonidine
  • Eye
  • Glaucoma
  • Intraocular pressure (IOP)

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension : A 12-month randomized trial. / Cantor, Louis; Safyan, Eleonora; Liu, Ching Chi; Batoosingh, Amy L.

In: Current Medical Research and Opinion, Vol. 24, No. 7, 07.2008, p. 2035-2043.

Research output: Contribution to journalArticle

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title = "Brimonidine-purite 0.1{\%} versus brimonidine-purite 0.15{\%} twice daily in glaucoma or ocular hypertension: A 12-month randomized trial",
abstract = "Objective: 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. Methods: 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). Main outcome measures: Mean change from baseline IOP and adverse events. Results: Demographics and baseline characteristics were similar between treatment groups. Treated-baseline mean IOPs at both timepoints were similar between groups (p ≥ 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. Conclusions: 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.",
keywords = "Brimonidine, Eye, Glaucoma, Intraocular pressure (IOP)",
author = "Louis Cantor and Eleonora Safyan and Liu, {Ching Chi} and Batoosingh, {Amy L.}",
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T1 - Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension

T2 - A 12-month randomized trial

AU - Cantor, Louis

AU - Safyan, Eleonora

AU - Liu, Ching Chi

AU - Batoosingh, Amy L.

PY - 2008/7

Y1 - 2008/7

N2 - Objective: 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. Methods: 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). Main outcome measures: Mean change from baseline IOP and adverse events. Results: Demographics and baseline characteristics were similar between treatment groups. Treated-baseline mean IOPs at both timepoints were similar between groups (p ≥ 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. Conclusions: 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.

AB - Objective: 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. Methods: 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). Main outcome measures: Mean change from baseline IOP and adverse events. Results: Demographics and baseline characteristics were similar between treatment groups. Treated-baseline mean IOPs at both timepoints were similar between groups (p ≥ 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. Conclusions: 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.

KW - Brimonidine

KW - Eye

KW - Glaucoma

KW - Intraocular pressure (IOP)

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