July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
12-month efficacy and safety of brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution in Korean patients with primary open-angle and normal-tension glaucomas–The KOCO Study
Author Affiliations & Notes
  • Sang Woo Park
    Department of Ophthalmology, Chonnam National University Medical School and Hospital, Gwangju, Korea (the Republic of)
  • Ki Ho Park
    Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea (the Republic of)
  • Joon Mo Kim
    Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of)
  • Ji Woong Lee
    Department of Ophthalmology, Pusan National University School of Medicine, Pusan, Korea (the Republic of)
  • Youkyung Lee
    Allergan Korea, Korea (the Republic of)
  • Joy Maglambayan
    Allergan Singapore Pte. Ltd., Singapore
  • Susan Simonyi
    Allergan Singapore Pte. Ltd., Singapore
  • Footnotes
    Commercial Relationships   Sang Woo Park, None; Ki Ho Park, None; Joon Mo Kim, None; Ji Woong Lee, None; Youkyung Lee, Allergan (E); Joy Maglambayan, Allergan (E); Susan Simonyi, Allergan (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 2391. doi:
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      Sang Woo Park, Ki Ho Park, Joon Mo Kim, Ji Woong Lee, Youkyung Lee, Joy Maglambayan, Susan Simonyi; 12-month efficacy and safety of brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution in Korean patients with primary open-angle and normal-tension glaucomas–The KOCO Study . Invest. Ophthalmol. Vis. Sci. 2019;60(9):2391.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Topical intraocular pressure (IOP)-lowering therapy has been shown to reduce glaucoma progression in both primary open-angle glaucoma (POAG) and normal-tension glaucoma (NTG). Little has been published on the efficacy of fixed-combination brimonidine 0.2%/timolol 0.5% (FCBT) in Korean patients who have a higher prevalence of NTG. Efficacy and safety of FCBT alone or with bimatoprost 0.01% (BIM) was assessed in Korean patients with POAG and NTG over 12 mo.

Methods : In this multicenter, open-label study, FCBT was administered twice daily in the study eye after washout of prior therapy. IOP was measured at visit 1 (baseline) and mo 1, 3, 6, 9 and 12. BIM rescue was permissible for IOP reduction <20% from baseline. Primary efficacy measure was mean change in IOP from baseline to mo 12 (11 AM). Secondary efficacy measures included mean duration of achieving target IOP with FCBT, proportion of patients achieving target IOP with FCBT, and rate of visual field (VF) progression over 12 mo. Safety measures included treatment-emergent adverse events (TEAEs).

Results : Of 118 enrolled eyes (78.8% [n=93] NTG; 21.2% [n=25] POAG), 87 remained on FCBT alone while 31 required BIM rescue; 29 patients discontinued from the study. Mean IOP change from baseline (16.8 mmHg [3.6 standard deviation (SD)] and 15.3 mmHg [3.1 SD]) to mo 12 (11 AM) with FCBT (n=62) and FCBT+BIM (n=27), respectively, was –4.1 and –3.1 mmHg (–24.0 and –19.6%; both P<.0001). On FCBT alone, 77 (88.5%) patients achieved target IOP in a mean of 1 mo. Rate of VF progression was 0.17 %/year (P=.837) with a mean change in mean deviation (MD) of 0.1 dB at mo 12 for FCBT and –0.08%/year with a mean change in MD of –0.12 dB for FCBT+BIM. Ocular TEAEs occurred in 42.5% and 71.0% of patients on FCBT and FCBT+BIM, respectively, were mostly Mild (M), and included ocular hyperemia (9.2% with FCBT: M=8.1%, Moderate (Mod)=1.2%, Severe (S)=0% and 41.9% with FCBT+BIM: M=38.7%, Mod=0%, S=3.2%), and dry eye (4.6% and 3.2%; M=100%).

Conclusions : Despite a mean baseline IOP of 16.8 mmHg, a persistent ≥20% IOP reduction from baseline to 12 mo was observed in patients receiving FCBT, with no observed significant VF progression over 12 mo. Consistent IOP reduction was noted in patients requiring additional BIM. Ocular TEAEs were in line with reported drug safety profiles.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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