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The Safety and Efficacy of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 2%/Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension

Manni, Gianluca MD*; Denis, Phillipe MD; Chew, Paul MD; Sharpe, Elisabeth D. MD§; Orengo-Nania, Silvia MD; Coote, Michael A. MD; Laganovska, Guna MD; Volksone, Lasma MD**; Zeyen, Thierry MD††; Filatori, Isabella BSc‡‡; James, John MS§§; Aung, Tin MD∥∥

doi: 10.1097/IJG.0b013e31818fb434
Original Studies

Purpose This study compared the intraocular pressure (IOP)-lowering efficacy of 2 fixed combination products, brinzolamide 1%/timolol 0.5% suspension (Azarga, Brinz/Tim) and dorzolamide 2%/timolol 0.5% solution (Dorz/Tim), in patients with open-angle glaucoma or ocular hypertension who required a change in therapy due to elevated IOP while receiving IOP-lowering medication.

Methods This was a one-year, multicenter, randomized, double-masked, active-controlled, parallel-group trial of Brinz/Tim and Dorz/Tim. IOP assessments were taken at 8 and 10 AM at week 2 and months 3 and 9, and at 8 AM, 10 AM, and 4 PM at months 6 and 12. Primary efficacy was a noninferiority comparison of mean IOP at the three month 6 time points.

Results Of the 437 patients enrolled, 220 dosed Brinz/Tim whereas 217 dosed Dorz/Tim twice daily. Brinz/Tim produced IOP-lowering efficacy comparable to Dorz/Tim, with the upper 95% confidence limits for the differences between groups within +1.5 mm Hg at all assessment times, including the month 6 primary efficacy time points, establishing noninferiority. Differences in means numerically favored Brinz/Tim at 9 of 12 study visits and times. The IOP reductions ranged from 7.2 to 9.2 mm Hg for Brinz/Tim and from 7.4 to 8.9 mm Hg for Dorz/Tim. Although a similar overall safety profile was observed between the 2 treatment groups, Brinz/Tim showed significantly less ocular irritation (2.7% vs. 10.6%; P=0.0009) than Dorz/Tim.

Conclusions Brinz/Tim suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is noninferior to Dorz/Tim. Additionally, Brinz/Tim affords an ocular comfort advantage compared with Dorz/Tim.

*University of Rome, Tor Vergata, Bietti Foundation IRCSS, Rome

‡‡Alcon Italia S.p.A, Milan, Italy

Ophthalmology Department, Hopital Edouard Herriot, Lyon, France

National University Hospital

∥∥Singapore National Eye Centre, Singapore

§Glaucoma Consultants and Center for Eye Research, Mount Pleasant, SC

Baylor College of Medicine, Houston

§§Alcon Research Ltd, Fort Worth, TX

The Royal Victorian Eye and Ear Hospital, and the Centre for Eye Research, Victoria, Australia

Department of Ophthalmology, P. Stradins Clinical University Hospital

**Glaucoma Service Outpatient Department, Clinical Hospital Gailezers, Riga, Latvia

††Ophthalmology Department, University Hospital, Leuven, Belgium

Funded by Alcon Laboratories Inc, Fort Worth, TX.

Reprints: Gianluca Manni, MD, Ophthalmology Department, University of Roma, Tor Vergata, V.le Oxford 81, Rome, Italy (e-mail: glmanni@inwind.it).

Received for publication April 16, 2008; accepted September 27, 2008

Competing Interests: Isabella Filatori and John James are Alcon Research employees.

Gianluca Manni: Consultant for Alcon, Allergan, Merck, Pfizer, and Sharp & Dohme; Phillipe Denis: Consultant for Alcon, Allergan, Pfizer; Silvia Orengo-Nania: Alcon—speaker's bureau and research funding; Thierry Zeyen: Speaker for Alcon, Allergan, Merck, and Pfizer; Tin Aung: Alcon—speaker's bureau, ad board participation, research funding, and travel support; Isabella Filatori and John James: Alcon employees.

The authors Paul Chew, Elisabeth D. Sharpe, Michael A. Coote, Guna Laganovska, and Lasma Volksone have nothing to disclose.

The statistical and safety analyses were performed by Alcon Research Ltd.

The manuscript was written with the collaboration of Alcon Research Ltd, reviewed and endorsed by the authors.

The academic authors were selected based on their contribution to the study.

© 2009 Lippincott Williams & Wilkins, Inc.