Bimatoprost 0.01% in treatment-naïve 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, Ki Ho Park, Susan Simonyi, Chan Yun Kim, Yong Ho Sohn, Michael Scott Kook

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.

Clinical trial registration number: NCT01594970.

Figures

Figure 1
Figure 1
Shift from baseline in hyperemia grading for all treatment-naïve patients. *Improved: +2, +3 to 0, +0.5, +1; worsened: 0, +0.5, +1 to +2, +3. †McNemar analysis.
Figure 2
Figure 2
Absolute (A) and percentage (B) IOP reductions from baseline for all treatment-naïve patients. Data are presented as mean ± SD. *P < 0.0001 (1-sample t-test). IOP = intraocular pressure.
Figure 3
Figure 3
Absolute (A) and percentage (B) IOP reductions from baseline for treatment-naïve patients, by baseline IOP. Data are presented as mean ± SD. *P < 0.0001 (1-sample t-test). IOP = intraocular pressure.

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Pre-publication history
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