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Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial.
Eye (Lond) 2016; 30(10):1343-1350E

Abstract

PurposeTo determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapyMethodsThis 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment. Masked treatments were instilled 3 times daily for 6 weeks, and patients continued once-daily use of their PGA. The primary efficacy end point was the between-group difference in mean diurnal IOP (average of 0800, 1000, 1500, and 1700 hours time points) at week 6.ResultsAt week 6, mean diurnal IOP with BBFC+PGA was lower than with vehicle+PGA (17.1±0.4 mm Hg vs 20.5±0.4 mm Hg; between-group difference, -3.4±0.5 mm Hg; P<0.0001; 95% confidence interval, -4.5 to -2.4 mm Hg). BBFC+PGA reduced mean diurnal IOP by 5.7 mm Hg (25%) from the baseline IOP achieved with PGA monotherapy.ConclusionsTherapy with BBFC produced an additive IOP-lowering effect compared with a PGA alone or in conjunction with vehicle. BBFC may provide an effective treatment option for patients receiving PGA monotherapy who require additional IOP reduction.

Authors+Show Affiliations

Department of Ophthalmology, SUNY Upstate Medical University, Syracuse, NY, USA.Wills Eye Hospital, Philadelphia, PA, USA.Alcon Laboratories, Inc., Fort Worth, TX, USA.Department of Ophthalmology, University of North Carolina, Chapel Hill, NC, USA.Clayton Eye Center, Morrow, GA, USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27367743

Citation

Fechtner, R D., et al. "Ocular Hypotensive Effect of Fixed-combination Brinzolamide/brimonidine Adjunctive to a Prostaglandin Analog: a Randomized Clinical Trial." Eye (London, England), vol. 30, no. 10, 2016, pp. 1343-1350.
Fechtner RD, Myers JS, Hubatsch DA, et al. Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial. Eye (Lond). 2016;30(10):1343-1350.
Fechtner, R. D., Myers, J. S., Hubatsch, D. A., Budenz, D. L., & DuBiner, H. B. (2016). Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial. Eye (London, England), 30(10), pp. 1343-1350. doi:10.1038/eye.2016.126.
Fechtner RD, et al. Ocular Hypotensive Effect of Fixed-combination Brinzolamide/brimonidine Adjunctive to a Prostaglandin Analog: a Randomized Clinical Trial. Eye (Lond). 2016;30(10):1343-1350. PubMed PMID: 27367743.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial. AU - Fechtner,R D, AU - Myers,J S, AU - Hubatsch,D A, AU - Budenz,D L, AU - DuBiner,H B, Y1 - 2016/07/01/ PY - 2015/12/18/received PY - 2016/05/05/accepted PY - 2016/7/2/pubmed PY - 2017/4/18/medline PY - 2016/7/2/entrez SP - 1343 EP - 1350 JF - Eye (London, England) JO - Eye (Lond) VL - 30 IS - 10 N2 - PurposeTo determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapyMethodsThis 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment. Masked treatments were instilled 3 times daily for 6 weeks, and patients continued once-daily use of their PGA. The primary efficacy end point was the between-group difference in mean diurnal IOP (average of 0800, 1000, 1500, and 1700 hours time points) at week 6.ResultsAt week 6, mean diurnal IOP with BBFC+PGA was lower than with vehicle+PGA (17.1±0.4 mm Hg vs 20.5±0.4 mm Hg; between-group difference, -3.4±0.5 mm Hg; P<0.0001; 95% confidence interval, -4.5 to -2.4 mm Hg). BBFC+PGA reduced mean diurnal IOP by 5.7 mm Hg (25%) from the baseline IOP achieved with PGA monotherapy.ConclusionsTherapy with BBFC produced an additive IOP-lowering effect compared with a PGA alone or in conjunction with vehicle. BBFC may provide an effective treatment option for patients receiving PGA monotherapy who require additional IOP reduction. SN - 1476-5454 UR - https://www.unboundmedicine.com/medline/citation/27367743/Ocular_hypotensive_effect_of_fixed_combination_brinzolamide/brimonidine_adjunctive_to_a_prostaglandin_analog:_a_randomized_clinical_trial_ L2 - http://dx.doi.org/10.1038/eye.2016.126 DB - PRIME DP - Unbound Medicine ER -