The Efficacy of Brinzolamide 1%/Brimonidine 0.2% Fixed Combination in Normal Tension Glaucoma

Hyun Uk Shin; Sang Wook Jin

doi:10.3341/jkos.2016.57.10.1619

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Shin and Jin: The Efficacy of Brinzolamide 1%/Brimonidine 0.2% Fixed Combination in Normal Tension Glaucoma

Original Article

J Korean Ophthalmol Soc 2016;57(10):1619-1624.

Published online: 25 September 2016

DOI: https://doi.org/10.3341/jkos.2016.57.10.1619

The Efficacy of Brinzolamide 1%/Brimonidine 0.2% Fixed Combination in Normal Tension Glaucoma

Hyun Uk Shin, MD, Sang Wook Jin, MD

Department of Ophthalmology, Dong-A University College of Medicine, Busan, Korea

Address reprint requests to Sang Wook Jin, MD Department of Ophthalmology, Dong-A University Hospital, #26 Daesingongwon-ro, Seo-gu, Busan 49201, Korea Tel: 82-51-240-5227, Fax: 82-51-254-1987 E-mail: jinnham@hanmail.net

Received 30 June 2016 Accepted 24 September 2016

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

To evaluate the efficacy and safety of brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) in normal tension glaucoma (NTG) patients.

Methods

This prospective study included patients treated with brinzolamide 1% monotherapy, brimonidine 0.2% monotherapy or brinzolamide 1% and brimonidine 0.2% concomitant therapy, as well as newly diagnosed NTG patients. The enrolled patients who used brinzolamide 1% or brimonidine 0.2% switched to BBFC and newly diagnosed NTG patients were treated with BBFC. The patients receiving brinzolamide 1% or brimonidine 0.2% monotherapy or brinzolamide 1% and brimonidine 0.2% concomitant therapy switched antiglaucoma drugs to BBFC. Newly diagnosed NTG patients used BBFC as the first therapy. The study consisted of 1 screening/baseline visit and 3 follow-up visits conducted after 1, 4, 8, 12 and 24 weeks of treatment. Intraocular pressure (IOP), mean deviation value and adverse drug reactions were evaluated before treatment and after treatment with BBFC.

Results

The mean IOP in the brinzolamide 1% monotherapy group was 13.5 ± 1.6 mm Hg and the mean IOP after switched from brinzolamide 1% monotherapy to BBFC was 12.1 ± 1.5 mm Hg. The mean IOP in the brimonidine 0.2% monotherapy group was 14.2 ± 1.3 mm Hg and the mean IOP after switched from brimonidine 0.2% monotherapy to BBFC was 11.7 ± 1.5 mm Hg. The mean IOP was 11.9 ± 2.1 mm Hg in the brinzolamide 1% and brimonidine 0.2% concomitant therapy group and the mean IOP after switched from brinzolamide 1% and brimonidine 0.2% concomitant therapy to BBFC was 12.0 ± 1.1 mm Hg. The mean IOP and reduction rate were 10.7 ± 2.1 mm Hg and 35.5%, respectively, in the newly diagnosed NTG patients treated with BBFC. There was no serious adverse drug reaction causing ocular damage.

Conclusions

BBFC provides a significant IOP reduction and is a safe antiglaucoma medication for NTG patients.

Keywords: Brimonidine, Brinzolamide, Fixed combination, Normal tension glaucoma

References

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Figure 1.

Changes of intraocular pressure (IOP) throughout the study (from brinzolamide 1% to BBFC switched group). Asterisk (*) indicated that statistically significant, p < 0.05, versus brinzolamide. BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination.

Figure 2.

Changes of intraocular pressure (IOP) throughout the study (from brimonidine 0.2% to BBFC switched group). Asterisk (*) indicated that statistically significant, p < 0.05, versus brimonidine. BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination.

Figure 3.

Changes of intraocular pressure (IOP) throughout the study (from brinzolamide 1% + brimonidine 0.2% to BBFC switched group). BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination.

Figure 4.

Changes of intraocular pressure (IOP) throughout the study (BBFC first therapy). Asterisk (*) indicated that statistically significant, p < 0.05, versus baseline. BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination.

Table 1.

Clinical and demographic data of the patients

	Data
Male:Female	40 (46.0%):47 (54.0%)
Mean age (years)	60.5 ± 5.4
Mean baseline IOP (mm Hg)	17.7 ± 1.7
Mean MD (dB)	–2.28 ± 0.12
Spherical equivalent (diopter)	–1.1 ± 2.0
CCT (mm)	547.2 ± 13.8

Values are presented as mean ± SD unless otherwise indicated.

Mean baseline IOP = intraocular pressure (IOP) before instillation of antiglaucoma eye-drops; MD = Mean deviation; CCT = central corneal thickness.

Table 2.

Mean IOP and change in mean and percentage of IOP from baseline (from brinzolamide1% to BBFC switched group, n = 24)

	Baseline^‡	Brinzolamide	Week 1	Week 4	Week 8	Week 12	Week 24
IOP (mm Hg)	17.3 ± 1.6	13.5 ± 1.6	12.4 ± 1.5	12.5 ± 1.4	12.5 ± 1.6	12.1 ± 1.5	12.1 ± 1.5
p-value^*	N/A	N/A	0.019	0.044	0.029	0.001	0.002
Reduction rate (%)	^† N/A	22.0	28.3	27.7	27.7	30.1	30.1

Values are presented as mean ± SD unless otherwise indicated.

IOP = intraocular pressure; BBFC = brimonidine 1%/brinzolamide 0.2% fixed combination; N/A = not applicable.

^* Paired-t test, Statistical significance: p < 0.05, vs. brinzolamide

^† vs. Baseline

^‡ Intraocular pressure before instillation of antiglaucoma eye-drops.

Table 3.

Mean IOP and change in mean and percentage of IOP from baseline (from brimonidine 0.2% to BBFC switched group, n = 30)

	Baseline^‡	Brimonidine	Week 1	Week 4	Week 8	Week 12	Week 24
IOP (mm Hg)	18.3 ± 1.7	14.2 ± 1.3	12.3 ± 1.5	12.6 ± 1.5	11.9 ± 1.9	11.8 ± 1.7	11.7 ± 1.5
p-value^*	N/A	N/A	<0.001	<0.001	<0.001	<0.001	<0.001
Reduction rate (%)^†	N/A	22.4	32.8	31.1	35.0	35.5	36.1

Values are presented as mean ± SD unless otherwise indicated.

IOP = intraocular pressure; BBFC = brimonidine 1%/brinzolamide 0.2% fixed combination; N/A = not applicable.

^* Paired-t test, Statistical significance: p < 0.05, vs. brimonidine

^† vs. Baseline

^‡ Intraocular pressure before instillation of antiglaucoma eye-drops.

Table 4.

Mean IOP and change in mean and percentage of IOP from baseline (n = 16)

	Baseline^‡	Brinzolamide + Brimonidine	Week 1	Week 4	Week 8	Week 12	Week 24
IOP (mm Hg)	19.7 ± 1.9	11.9 ± 2.1	12.2 ± 1.3	12.3 ± 1.1	11.8 ± 1.6	12.1 ± 1.7	12.0 ± 1.1
p-value^*	N/A	N/A	0.700	0.616	0.880	0.852	0.891
Reduction rate (%)^†	^† N/A	39.6	38.1	37.6	40.1	38.6	39.1

Values are presented as mean ± SD unless otherwise indicated (from brinzolamide 1% + brimonidine 0.2% to BBFC switched group).

IOP = intraocular pressure; N/A = not applicable; BBFC = brimonidine 1% / brinzolamide 0.2% fixed combination.

^* Paired-t test, Statistical significance: p < 0.05, vs. brinzolamide + brimonidine

^† vs. Baseline

^‡ Intraocular pressure before instillation of antiglaucoma eye-drops.

Table 5.

Mean IOP and change in mean and percentage of IOP from baseline (BBFC first therapy group, n = 17)

	Baseline^‡	Week 1	Week 4	Week 8	Week 12	Week 24
IOP (mm Hg)	16.6 ± 1.7	11.3 ± 1.6	10.8 ± 1.6	10.9 ± 2.1	11.1 ± 2.0	10.7 ± 2.1
p-value^*	N/A	0.000	0.000	0.000	0.000	0.000
Reduction rate (%)^†	N/A	32.0	34.9	34.3	33.1	35.5

Values are presented as mean ± SD unless otherwise indicated.

IOP = intraocular pressure; BBFC = brimonidine 1%/brinzolamide 0.2% fixed combination; N/A = not applicable.

^* Paired-t test, Statistical significance: p < 0.05, vs. baseline

^† vs. baseline

^‡ Intraocular pressure before instillation of antiglaucoma eye-drops.

Table 6.

Adverse drug reactions

Adverse drug reactions (n = 19, 21.8%)	Number (%)
Hyperemia	5 (5.7)
Allergic conjunctivitis	4 (4.6)
Eye irritation	3 (3.4)
Dry mouth	3 (3.4)
Blurred vision	3 (3.4)
Foreign body sensation	1 (1.1)

Values are presented as n (%).

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