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; Chan Yun Kim; Yong Ho Sohn; Michael Scott Kook

doi:10.1186/1471-2415-14-160

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, Chan Yun Kim, Yong Ho Sohn, Michael Scott Kook

Department of Ophthalmology

Research output: Contribution to journal › Article › peer-review

5 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 language	English
Article number	160
Journal	BMC Ophthalmology
Volume	14
Issue number	1
DOIs	https://doi.org/10.1186/1471-2415-14-160
Publication status	Published - 2014 Dec 17

Bibliographical note

Funding Information:
This study was supported by Allergan Singapore Pte, Ltd. Neither honoraria nor payments were made for authorship. The funding body was involved in the design, data analysis and interpretation, revision of the manuscript for intellectual content, and decision to submit the manuscript for publication. Writing and editorial assistance was provided to the authors by Paul Littlebury, PhD and Michele Jacob, PhD of Evidence Scientific Solutions, Philadelphia, PA and funded by Allergan, Inc., Irvine, CA.

Publisher Copyright:
© 2014 Park et al.

All Science Journal Classification (ASJC) codes

Ophthalmology

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10.1186/1471-2415-14-160

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 Kim, {Chan Yun} and Sohn, {Yong Ho} and Kook, {Michael Scott}",

note = "Funding Information: This study was supported by Allergan Singapore Pte, Ltd. Neither honoraria nor payments were made for authorship. The funding body was involved in the design, data analysis and interpretation, revision of the manuscript for intellectual content, and decision to submit the manuscript for publication. Writing and editorial assistance was provided to the authors by Paul Littlebury, PhD and Michele Jacob, PhD of Evidence Scientific Solutions, Philadelphia, PA and funded by Allergan, Inc., Irvine, CA. Publisher Copyright: {\textcopyright} 2014 Park et al.",

year = "2014",

month = dec,

day = "17",

doi = "10.1186/1471-2415-14-160",

language = "English",

volume = "14",

journal = "BMC Ophthalmology",

issn = "1471-2415",

publisher = "BioMed Central",

number = "1",

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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, Chan Yun

AU - Sohn, Yong Ho

AU - Kook, Michael Scott

N1 - Funding Information: This study was supported by Allergan Singapore Pte, Ltd. Neither honoraria nor payments were made for authorship. The funding body was involved in the design, data analysis and interpretation, revision of the manuscript for intellectual content, and decision to submit the manuscript for publication. Writing and editorial assistance was provided to the authors by Paul Littlebury, PhD and Michele Jacob, PhD of Evidence Scientific Solutions, Philadelphia, PA and funded by Allergan, Inc., Irvine, CA. Publisher Copyright: © 2014 Park et al.

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

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