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Additive effects of brimonidine tartrate 0.1%/brinzolamide 1% fixed-dose combination in prostaglandin analog-treated Japanese glaucoma patients

  • Clinical Investigation
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A Correction to this article was published on 22 November 2023

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Abstract

Purpose

A brimonidine tartrate 0.1%/brinzolamide 1% fixed-dose combination (BBFC) was recently approved for glaucoma and ocular hypertension treatment in Japan. We investigated the efficacy and safety of BBFC used concomitantly with prostaglandin analogs (PG) or a PG/beta-blocker fixed-dose combination (PG/beta FC).

Study design

This was a prospective, open-label, multicenter study.

Patients and methods

We enrolled Japanese patients with open-angle glaucoma. BBFC (Ailamide) was concomitantly administered to either the PG or the PG/beta FC group, and intraocular pressure (IOP) and safety were evaluated at 4 and 12 weeks. The groups were stratified into low and high IOP baseline groups based on the median baseline IOP.

Results

We enrolled 100 patients, 91 of whom completed the 12-week follow-up. The mean ages were 67.1 and 65.7 years in the PG group (n = 45, baseline IOP of 15.7 ± 2.3 mmHg) and the PG/beta FC group (n = 46, baseline IOP of 16.3 ± 2.3 mmHg), respectively. After BBFC administration, IOPs at 4 and 12 weeks were 13.0 ± 2.0 and 13.0 ± 2.6 mmHg (P < 0.0001) in the PG group, respectively, and 13.7 ± 2.4 and 13.7 ± 2.2 mmHg (P < 0.0001) in the PG/beta FC group, respectively. IOP decreased by – 2.0 ± 1.8 mmHg (P < 0.0001) and –1.9 ± 1.4 mmHg (P < 0.0001) in the low baseline PG group (14.1 mmHg) and low baseline PG/beta FC group (14.8 mmHg) at 12 weeks, respectively. Sixteen adverse events were identified, all of which were common and did not affect visual acuity.

Conclusions

BBFC can be used concomitantly with PG or PG/beta FC to reduce IOP without serious complications.

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Acknowledgements

We would like to thank Mr Katsunobu Takahashi (RPM) for conducting the statistical analysis. We thank Mr Yoshiyuki Tamada (Senju Pharmaceutical) for his research assistance. We also thank Editage (http://www.editage.com) for English language editing.

Funding

This study was funded by Senju Pharmaceutical (Osaka, Japan).

Author information

Authors and Affiliations

  1. Department of Ophthalmology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Rei Sakata & Makoto Aihara

  2. Yotsuya Shirato Eye Clinic, Yotsuya, Tokyo, Japan

    Rei Sakata & Makoto Aihara

  3. Department of Ophthalmology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan

    Shiro Mizoue

  4. Department of Ophthalmology, Minami-Matsuyama Hospital, Matsuyama, Ehime, Japan

    Shiro Mizoue

  5. Yoshikawa Eye Clinic, Machida, Tokyo, Japan

    Keiji Yoshikawa

  6. Eye Rose Clinic, Chiyoda, Tokyo, Japan

    Misato Adachi

  7. Ohkubo Eye Clinic, Kanazawa, Ishikawa, Japan

    Shinji Ohkubo

  8. Omiya Hamada Eye Clinic, Saitama, Saitama, Japan

    Naoki Hamada

  9. Grace Eye Clinic, Okayama, Okayama, Japan

    Tomoko Naito

  10. Muramatsu Eye Clinic, Susono, Shizuoka, Japan

    Tomoyuki Muramatsu

  11. Hara Eye Hospital, Utsunomiya, Tochigi, Japan

    Takeshi Hara

  12. Asato Eye Clinic, Naha, Okinawa, Japan

    Ryo Asato

Authors
  1. Rei Sakata
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  2. Shiro Mizoue
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  3. Keiji Yoshikawa
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  4. Misato Adachi
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  11. Makoto Aihara
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Corresponding author

Correspondence to Makoto Aihara.

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Conflict of interest

R. Sakata, Grant (Santen, Novartis, TOMEY); S. Mizoue, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (Santen, Kowa, Novartis, Otsuka Pfizer); K. Yoshikawa, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (Santen, Otsuka, Novartis, RE Medical), M. Adachi, None; S. Ohkubo, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (Santen, Pfizer, Viatris, Alcon, JFC Sales Plan, Beeline, Nitto Medic, Sucampo, ZEISS, JFC, Heidelberg Engineering, Otsuka); N. Hamada, None; T. Naito, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (Santen, Otsuka, Novartis, Kowa); T. Muramatsu, None; T. Hara, None; R. Asato, None; M. Aihara, Consulting fees (Santen, Senju, Alcon, Pfizer, Kowa, Otsuka, Wakamoto, Glaukos, HOYA, IRIDEX, Astellas), Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events (Santen, Senju, Alcon, Pfizer, Kowa, Otsuka, Wakamoto, Glaukos, HOYA, IRIDEX, Astellas, CANON, ZEISS).

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Corresponding Author: Makoto Aihara

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Sakata, R., Mizoue, S., Yoshikawa, K. et al. Additive effects of brimonidine tartrate 0.1%/brinzolamide 1% fixed-dose combination in prostaglandin analog-treated Japanese glaucoma patients. Jpn J Ophthalmol 67, 668–677 (2023). https://doi.org/10.1007/s10384-023-01022-6

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  • DOI: https://doi.org/10.1007/s10384-023-01022-6

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