Twice-Daily Brinzolamide/Brimonidine Fixed Combination versus Brinzolamide or Brimonidine in Open-Angle Glaucoma or Ocular Hypertension

      Purpose

      To compare the intraocular pressure (IOP)-lowering efficacy and safety of brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) with that of brinzolamide 1% or brimonidine 0.2% monotherapy, all dosed 2 times per day (BID).

      Design

      Six-month, phase 3, randomized, multicenter, double-masked clinical trial.

      Participants

      A total of 560 patients with primary open-angle glaucoma or ocular hypertension who had insufficient IOP reduction with their current therapeutic regimen or who were receiving ≥2 IOP-lowering medications.

      Intervention

      Patients received BBFC (n = 193), brinzolamide 1% (n = 192), or brimonidine 0.2% (n = 175) BID.

      Main Outcome Measures

      The primary end point was mean change in diurnal IOP from baseline to month 3. Supportive end points included mean diurnal IOP change from baseline at week 2, week 6, and month 6; and mean IOP, mean IOP change from baseline, mean percentage IOP change from baseline, and percentage of patients with IOP <18 mmHg at week 2, week 6, month 3, and month 6 at each assessment time point (i.e., 9 am, 11 am, and 4 pm). Adverse events were recorded throughout the study.

      Results

      Baseline diurnal IOP was similar among groups (mean ± standard deviation: BBFC, 25.9±0.19 mmHg; brinzolamide, 25.9±0.20 mmHg; brimonidine, 26.0±0.19 mmHg). At month 3, BBFC lowered mean diurnal IOP from baseline to a significantly greater extent than brinzolamide (least squares [LS] mean difference: −1.4 mmHg; P < 0.0001; t test) and brimonidine (LS mean difference: −1.5 mmHg; P < 0.0001). All supportive end points corroborated the results of the primary efficacy analysis. Mean percentage reductions in IOP from baseline were 26.7% to 36.0% with BBFC, 22.4% to 27.9% with brinzolamide, and 20.6% to 31.3% with brimonidine. The most common adverse drug reactions were ocular side effects, including hyperemia, blurred vision, allergic-type reactions, and discomfort. The incidence of hyperemia of the eye was slightly lower with brinzolamide than with BBFC and brimonidine, whereas blurred vision and ocular discomfort were slightly more common with BBFC than with brinzolamide or brimonidine.

      Conclusions

      Brinzolamide 1% and brimonidine 0.2% fixed combination administered BID had a significantly greater IOP-lowering effect than either brinzolamide or brimonidine alone and displayed a safety profile consistent with its individual components.

      Abbreviations and Acronyms:

      AE ( adverse event), BBFC ( brinzolamide 1% and brimonidine 0.2% fixed combination), BCVA ( best-corrected visual acuity), BID ( 2 times per day), IOP ( intraocular pressure), ITT ( intent-to-treat), LS ( least squares), SAE ( serious adverse event), SD ( standard deviation), TID ( 3 times per day)
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      Linked Article

      • Corrigendum
        OphthalmologyVol. 122Issue 10
        • In Brief
          With apologies from the authors, the publication titled “Twice-Daily Brinzolamide/Brimonidine Fixed Combination versus Brinzolamide or Brimonidine in Open-Angle Glaucoma or Ocular Hypertension,” (Ophthalmology 2014;121:2348-55) had an error.
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