Clinical Effectiveness of a Brinzolamide 1%-Brimonidine 0.2% Fixed Combination for Normal Tension Glaucoma in South Koreans

In Tae Kim; Jeong Hun Bae; Joon Mo Kim

doi:10.3341/jkos.2018.59.6.561

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Kim, Bae, and Kim: Clinical Effectiveness of a Brinzolamide 1%-Brimonidine 0.2% Fixed Combination for Normal Tension Glaucoma in South Koreans

Original Article

J Korean Ophthalmol Soc 2018;59(6):561-568.

Published online: 25 September 2018

DOI: https://doi.org/10.3341/jkos.2018.59.6.561

Clinical Effectiveness of a Brinzolamide 1%-Brimonidine 0.2% Fixed Combination for Normal Tension Glaucoma in South Koreans

In Tae Kim, MD, Jeong Hun Bae, MD, PhD, Joon Mo Kim, MD, PhD

Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea

Address reprint requests to Joon Mo Kim, MD, PhD Department of Ophthalmology, Kangbuk Samsung Hospital, #29 Saemunan-ro, Jongno-gu, Seoul 03181, Korea Tel: 82-2-2001-2250, Fax: 82-2-2001-2262 E-mail: kjoonmo1@gmail.com

Received 1 February 2018 Revised 4 April 2018 Accepted 4 June 2018

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

This study evaluated the efficacy and safety of a brinzolamide 1%-brimonidine 0.2% fixed combination (BBFC) for normal tension glaucoma (NTG) in a South Korean population.

Methods

This study included 45 patients who were newly diagnosed with NTG and treated with BBFC as the first therapy from January 2016 through December 2016. The unilateral eye of NTG eyes of all patients were enrolled. If both eyes were eligible, the eye with the more severe glaucomatous change was selected. If the glaucomatous change was similar in both eyes, the right eye was selected. The patients received the BBFC twice a day. Diurnal intraocular pressure (IOP) was measured every 2 and 1/2 hours between 09:00 am and 04:30 pm. The IOP change with respect to body position (positional IOP) was measured at baseline and at 6 months after eyedrop instillation. Throughout the study, all side effects were recorded and monitored by the investigators.

Results

Ten patients were excluded due to an allergic reaction or follow-up loss. A total of 35 patients were enrolled in this study. The mean IOP was 15.32 ± 4.00 mmHg at baseline and 13.38 ± 3.30 mmHg at 6 months after BBFC instillation (p < 0.001). The IOP fluctuation decreased from 3.33 ± 3.10 to 2.35 ± 1.40 mmHg after BBFC instillation; however, the difference was not statistically significant (p = 0.150). The mean change in positional IOP showed a statistically significant reduction from 16.94 ± 3.18 to 14.80 ± 3.27 mmHg (p = 0.025). There was no serious adverse drug reaction except in three cases of allergic reaction.

Conclusions

BBFC is effective for the reduction of mean IOP and positional IOP in NTG patients.

Keywords: Brinzolamide 1%-Brimonidine 0.2% fixed combination, Normal tension glaucoma

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Figure 1.

Time course data for intraocular pressure (IOP) at baseline and 6 months after brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) instillation. The mean change of IOP showed significant reduction at each time.

Figure 2.

Positional intraocular pressure (IOP) changes at baseline and 6 months after brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) instillation. The mean change of positional IOP showed significant reduction at each position.

Figure 3.

Intraocular pressure (IOP) change after instillation of brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) drug. The baseline IOP was 15.32 ± 4.00 mmHg. After use of BBFC, the mean IOP was decreased to 13.62 ± 4.22 mmHg (1 month) 13.44 ± 3.80 mmHg (3 months) and 13.38 ± 3.30 mmHg (6 months).

Table 1.

Profile and demograph ics of the patients

Variables	Value
Patients who prescribed BBFC	45
Stop BBFC due to allergy	3
Stop BBFC due to ineffectiveness	3
Follow up loss	4
Number of final patients used BBF	35
	(unilateral 10, bilateral 25)
Mean age (years)	50.59 ± 4.16
Sex (male:female) (n, %)	20 (57.1):15 (42.9)
DM (n, %)	7 (20.0)
HTN (n, %)	6 (17.1)
Baseline BCVA	0.82 ± 0.16
Mean MD (dB)	–2.35 ± 0.18
CCT (μ m)	551.3 ± 12.9

Values are presented as mean ± SD or n (%) unless otherwise indicated.

BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination; DM = diabetic mellitus; HTN = hypertension; BCVA = best corrected visual acuity; MD = mean deviation; CCT = central corneal thickness.

Table 2.

IOP changes at 6 months after BBFC instillation from baseline

Diurnal IOP	IOP (mmHg)		Measured IOP change on (mmHg)	p-value^*
Diurnal IOP	At baseline At 6	months after eyedrop instillati	Measured IOP change on (mmHg)	p-value^*
9 a.m.	16.12 ± 4.02	14.06 ± 3.20	3.09 (19.20)	<0.001
11:30 a.m.	16.10 ± 4.47	13.66 ± 3.66	2.26 (14.08)	<0.001
2 p.m.	14.94 ± 3.90	13.36 ± 3.21	1.60 (10.70)	0.001
4:30 p.m.	15.10 ± 3.52	13.94 ± 3.54	0.98 (6.48)	0.018
Mean	15.32 ± 4.00	13.38 ± 3.30	1.94 (12.65)	<0.001
IOP fluctuation (Highest IOP – Lowest IOP)	3.33 ± 3.10	2.35 ± 1.40	–	0.150

Values are presented as mean ± SD or n (%) unless otherwise indicated.

IOP = intraocular pressure; BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination.

^* Analyzed with the paired t-test.

Table 3.

IOP changes dependent on body position at 6 months after BBFC instillation

Position	IOP (mmHg)		Measured IOP change (mmHg) (n, %)	p-value^*
Position	At baseline At 6	months after eyedrop instillation	Measured IOP change (mmHg) (n, %)	p-value^*
Both eye BBFC use (n = 25	5)^†
Supine	18.86 ± 3.32	15.63 ± 3.12	3.15 (16.70)	<0.001
Right lateral decubitus
Right case^‡ (n = 15)^†
Right eye	17.49 ± 3.48	15.12 ± 3.61	2.37 (13.55)	0.005
Left eye	17.19 ± 3.38	14.98 ± 3.50	2.21 (12.85)	0.012
Left lateral decubitus
Left case^‡ (n = 10)^†
Right eye	16.69 ± 3.45	14.72 ± 3.05	1.97 (11.80)	0.015
Left eye	16.98 ± 2.95	15.02 ± 2.81	1.96 (11.54)	0.040
Single eye BBFC use (n =	10)^†
Right BBFC eye (n = 5)^†
Supine	18.22 ± 3.09	15.23 ± 2.89	2.99 (16.41)	0.011
Right lateral decubitus
Right eye	17.62 ± 3.52	15.45 ± 3.83	2.17 (12.32)	0.042
Left eye	16.89 ± 3.08	14.70 ± 3.49	2.19 (12.97)	0.031
Left lateral decubitus
Right eye	17.04 ± 3.41	14.98 ± 3.77	2.06 (12.09)	0.045
Left eye	17.32 ± 3.69	15.24 ± 3.73	2.08 (12.01)	0.029
Left BBFC eye (n = 5)^†
Supine	18.39 ± 3.15	15.36 ± 3.02	3.03 (16.47)	0.005
Right lateral decubitus
Right eye	17.42 ± 3.70	15.49 ± 3.22	1.93 (11.08)	0.035
Left eye	17.02 ± 4.01	15.10 ± 3.19	1.92 (11.28)	0.028
Left lateral decubitus
Right eye	16.59 ± 4.11	14.71 ± 3.01	1.88 (11.33)	0.048
Left eye	17.22 ± 3.86	15.32 ± 3.17	1.90 (11.03)	0.033
Sitting	14.93 ± 3.17	13.73 ± 3.44	1.23 (8.36)	0.022
Mean	16.94 ± 3.18	14.80 ± 3.27	2.13 (12.63)	0.025

Values are presented as mean ± SD or n (%) unless otherwise indicated.

IOP = intraocular pressure; BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination.

^* Analyzed with the paired t-test

^† Number of cases included this study

^‡ Case was defined as enrolled eye of the patients using BBFC in both eye.

Table 4.

IOP changes of dependent eye (lower position) at lateral decubitus position after BBFC instillation

Position	IOP (mmHg)		Measured IOP change (mmHg) (n, %)	p-value^*
Position	At baseline At 6	months after eyedrop instillatio	Measured IOP change (mmHg) (n, %)	p-value^*
Right eye BBFC use (n =20)^†
Right lateral decubitus
Right eye	17.52 ± 3.49	15.20 ± 3.67	2.32 (13.24)	0.010
Left eye BBFC use (n = 15)^†
Left lateral decubitus
Left eye	16.99 ± 3.30	14.83 ± 2.94	2.16 (12.71)	0.026

Values are presented as mean ± SD or n (%) unless otherwise indicated.

IOP = intraocular pressure; BBFC = brinzolamide 1%/brimonidine 0.2% fixed combination.

^* Analyzed with the paired t-test

^† Number of cases included this study.

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