Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension: An observational study in the Korean clinical setting

Ki Ho Park, Susan Simonyi, chanyun kim, Yong Ho Sohn, Michael Scott Kook

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3 Citations (Scopus)

Abstract

Background: This study evaluates the efficacy and tolerability (ie, occurrence and severity of hyperemia) of bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma (OAG) or ocular hypertension in the Korean clinical setting. Methods: In this multicenter, open-label, observational study, treatment-naïve patients with OAG, including patients with normal-tension glaucoma (NTG, defined as IOP ≤21 mm Hg), or ocular hypertension received bimatoprost 0.01% once daily. Hyperemia was assessed at baseline and weeks 6 and 12, graded by a masked evaluator using a photonumeric scale (0, +0.5, +1, +2, +3), and grouped as (0 to +1) and (+2 to +3). Shifts between groupings were reported as no change, improved ([+2 to +3] to [0 to +1]), or worsened ([0 to +1] to [+2 to +3]). Other adverse events were monitored. Mean IOP changes from baseline at weeks 6 and 12 were reported. Supplemental analyses were conducted for IOPs >21 versus ≥21 mm Hg. Results: Of 295 treatment-naïve patients included in the intent-to-treat/safety population, 73 (24.7%) had baseline IOP >21 mm Hg (mean, 25.7 ± 5.0 mm Hg) and 222 (75.3%) had baseline IOP =21 mm Hg (mean, 16.3 ± 3.0 mm Hg); 96.3% had hyperemia graded none (36.3%) to mild (17.3%). At week 12, hyperemia was graded none to mild in 83.7% (n = 220). Worsening occurred in 12.3% of patients by week 6 and 12.7% by week 12. Small improvements occurred in 0.8% and 0.5% of patients at weeks 6 and 12, respectively. Hyperemia scores were generally low and the majority of patients had no change in severity during the study. Mean IOP at weeks 6 and 12 was reduced to 16.4 ± 4.0 mm Hg (-34.5%; P < 0.0001) and 16.7 ± 3.9 mm Hg (-32.0%; P < 0.001) in the baseline-IOP >21 mm Hg group versus 13.3 ± 2.6 mm Hg (-17.8%; P < 0.001) and 13.7 ± 2.8 mm Hg (-15.9%; P < 0.001) in the baseline-IOP =21 mm Hg group, respectively. Conclusions: In treatment-naïve patients, bimatoprost 0.01% induced low shifts in worsening of hyperemia and significant reductions in IOP, regardless of baseline IOP.

Original languageEnglish
Article number160
JournalBMC Ophthalmology
Volume14
Issue number1
DOIs
Publication statusPublished - 2014 Dec 17

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Ocular Hypertension
Open Angle Glaucoma
Observational Studies
Hyperemia
Therapeutics
Low Tension Glaucoma
Bimatoprost
Safety

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

@article{45376d0b8c8942d29a7e5a78dadf1136,
title = "Bimatoprost 0.01{\%} in treatment-naive patients with open-angle glaucoma or ocular hypertension: An observational study in the Korean clinical setting",
abstract = "Background: This study evaluates the efficacy and tolerability (ie, occurrence and severity of hyperemia) of bimatoprost 0.01{\%} in treatment-na{\"i}ve patients with open-angle glaucoma (OAG) or ocular hypertension in the Korean clinical setting. Methods: In this multicenter, open-label, observational study, treatment-na{\"i}ve patients with OAG, including patients with normal-tension glaucoma (NTG, defined as IOP ≤21 mm Hg), or ocular hypertension received bimatoprost 0.01{\%} once daily. Hyperemia was assessed at baseline and weeks 6 and 12, graded by a masked evaluator using a photonumeric scale (0, +0.5, +1, +2, +3), and grouped as (0 to +1) and (+2 to +3). Shifts between groupings were reported as no change, improved ([+2 to +3] to [0 to +1]), or worsened ([0 to +1] to [+2 to +3]). Other adverse events were monitored. Mean IOP changes from baseline at weeks 6 and 12 were reported. Supplemental analyses were conducted for IOPs >21 versus ≥21 mm Hg. Results: Of 295 treatment-na{\"i}ve patients included in the intent-to-treat/safety population, 73 (24.7{\%}) had baseline IOP >21 mm Hg (mean, 25.7 ± 5.0 mm Hg) and 222 (75.3{\%}) had baseline IOP =21 mm Hg (mean, 16.3 ± 3.0 mm Hg); 96.3{\%} had hyperemia graded none (36.3{\%}) to mild (17.3{\%}). At week 12, hyperemia was graded none to mild in 83.7{\%} (n = 220). Worsening occurred in 12.3{\%} of patients by week 6 and 12.7{\%} by week 12. Small improvements occurred in 0.8{\%} and 0.5{\%} of patients at weeks 6 and 12, respectively. Hyperemia scores were generally low and the majority of patients had no change in severity during the study. Mean IOP at weeks 6 and 12 was reduced to 16.4 ± 4.0 mm Hg (-34.5{\%}; P < 0.0001) and 16.7 ± 3.9 mm Hg (-32.0{\%}; P < 0.001) in the baseline-IOP >21 mm Hg group versus 13.3 ± 2.6 mm Hg (-17.8{\%}; P < 0.001) and 13.7 ± 2.8 mm Hg (-15.9{\%}; P < 0.001) in the baseline-IOP =21 mm Hg group, respectively. Conclusions: In treatment-na{\"i}ve patients, bimatoprost 0.01{\%} induced low shifts in worsening of hyperemia and significant reductions in IOP, regardless of baseline IOP.",
author = "Park, {Ki Ho} and Susan Simonyi and chanyun kim and Sohn, {Yong Ho} and Kook, {Michael Scott}",
year = "2014",
month = "12",
day = "17",
doi = "10.1186/1471-2415-14-160",
language = "English",
volume = "14",
journal = "BMC Ophthalmology",
issn = "1471-2415",
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Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension : An observational study in the Korean clinical setting. / Park, Ki Ho; Simonyi, Susan; kim, chanyun; Sohn, Yong Ho; Kook, Michael Scott.

In: BMC Ophthalmology, Vol. 14, No. 1, 160, 17.12.2014.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Bimatoprost 0.01% in treatment-naive patients with open-angle glaucoma or ocular hypertension

T2 - An observational study in the Korean clinical setting

AU - Park, Ki Ho

AU - Simonyi, Susan

AU - kim, chanyun

AU - Sohn, Yong Ho

AU - Kook, Michael Scott

PY - 2014/12/17

Y1 - 2014/12/17

N2 - Background: This study evaluates the efficacy and tolerability (ie, occurrence and severity of hyperemia) of bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma (OAG) or ocular hypertension in the Korean clinical setting. Methods: In this multicenter, open-label, observational study, treatment-naïve patients with OAG, including patients with normal-tension glaucoma (NTG, defined as IOP ≤21 mm Hg), or ocular hypertension received bimatoprost 0.01% once daily. Hyperemia was assessed at baseline and weeks 6 and 12, graded by a masked evaluator using a photonumeric scale (0, +0.5, +1, +2, +3), and grouped as (0 to +1) and (+2 to +3). Shifts between groupings were reported as no change, improved ([+2 to +3] to [0 to +1]), or worsened ([0 to +1] to [+2 to +3]). Other adverse events were monitored. Mean IOP changes from baseline at weeks 6 and 12 were reported. Supplemental analyses were conducted for IOPs >21 versus ≥21 mm Hg. Results: Of 295 treatment-naïve patients included in the intent-to-treat/safety population, 73 (24.7%) had baseline IOP >21 mm Hg (mean, 25.7 ± 5.0 mm Hg) and 222 (75.3%) had baseline IOP =21 mm Hg (mean, 16.3 ± 3.0 mm Hg); 96.3% had hyperemia graded none (36.3%) to mild (17.3%). At week 12, hyperemia was graded none to mild in 83.7% (n = 220). Worsening occurred in 12.3% of patients by week 6 and 12.7% by week 12. Small improvements occurred in 0.8% and 0.5% of patients at weeks 6 and 12, respectively. Hyperemia scores were generally low and the majority of patients had no change in severity during the study. Mean IOP at weeks 6 and 12 was reduced to 16.4 ± 4.0 mm Hg (-34.5%; P < 0.0001) and 16.7 ± 3.9 mm Hg (-32.0%; P < 0.001) in the baseline-IOP >21 mm Hg group versus 13.3 ± 2.6 mm Hg (-17.8%; P < 0.001) and 13.7 ± 2.8 mm Hg (-15.9%; P < 0.001) in the baseline-IOP =21 mm Hg group, respectively. Conclusions: In treatment-naïve patients, bimatoprost 0.01% induced low shifts in worsening of hyperemia and significant reductions in IOP, regardless of baseline IOP.

AB - Background: This study evaluates the efficacy and tolerability (ie, occurrence and severity of hyperemia) of bimatoprost 0.01% in treatment-naïve patients with open-angle glaucoma (OAG) or ocular hypertension in the Korean clinical setting. Methods: In this multicenter, open-label, observational study, treatment-naïve patients with OAG, including patients with normal-tension glaucoma (NTG, defined as IOP ≤21 mm Hg), or ocular hypertension received bimatoprost 0.01% once daily. Hyperemia was assessed at baseline and weeks 6 and 12, graded by a masked evaluator using a photonumeric scale (0, +0.5, +1, +2, +3), and grouped as (0 to +1) and (+2 to +3). Shifts between groupings were reported as no change, improved ([+2 to +3] to [0 to +1]), or worsened ([0 to +1] to [+2 to +3]). Other adverse events were monitored. Mean IOP changes from baseline at weeks 6 and 12 were reported. Supplemental analyses were conducted for IOPs >21 versus ≥21 mm Hg. Results: Of 295 treatment-naïve patients included in the intent-to-treat/safety population, 73 (24.7%) had baseline IOP >21 mm Hg (mean, 25.7 ± 5.0 mm Hg) and 222 (75.3%) had baseline IOP =21 mm Hg (mean, 16.3 ± 3.0 mm Hg); 96.3% had hyperemia graded none (36.3%) to mild (17.3%). At week 12, hyperemia was graded none to mild in 83.7% (n = 220). Worsening occurred in 12.3% of patients by week 6 and 12.7% by week 12. Small improvements occurred in 0.8% and 0.5% of patients at weeks 6 and 12, respectively. Hyperemia scores were generally low and the majority of patients had no change in severity during the study. Mean IOP at weeks 6 and 12 was reduced to 16.4 ± 4.0 mm Hg (-34.5%; P < 0.0001) and 16.7 ± 3.9 mm Hg (-32.0%; P < 0.001) in the baseline-IOP >21 mm Hg group versus 13.3 ± 2.6 mm Hg (-17.8%; P < 0.001) and 13.7 ± 2.8 mm Hg (-15.9%; P < 0.001) in the baseline-IOP =21 mm Hg group, respectively. Conclusions: In treatment-naïve patients, bimatoprost 0.01% induced low shifts in worsening of hyperemia and significant reductions in IOP, regardless of baseline IOP.

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U2 - 10.1186/1471-2415-14-160

DO - 10.1186/1471-2415-14-160

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