Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

Jonathan S Myers, Steven Vold, Fiaz Zaman, Julia M Williams, David A Hollander, Jonathan S Myers, Steven Vold, Fiaz Zaman, Julia M Williams, David A Hollander

Abstract

Background: The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma.

Methods: Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03%) are presented.

Results: Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean) was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957). In both treatment arms, mean (± standard error of the mean) reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001), ranging from 3.7±0.4 (17.0%) mmHg to 4.4±0.4 (19.9%) mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8%) mmHg to 3.9±0.5 (16.7%) mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival hyperemia of mild or greater severity increased from latanoprost baseline after 12 weeks of treatment only in the bimatoprost 0.03% treatment arm.

Conclusion: Many patients who do not reach their target IOP on latanoprost can achieve additional IOP lowering and maintain monotherapy by replacing latanoprost with bimatoprost. Reductions in IOP from latanoprost baseline were larger with bimatoprost 0.01% than with bimatoprost 0.03%, and bimatoprost 0.01% had a more favorable tolerability profile.

Keywords: bimatoprost; intraocular pressure; latanoprost; monotherapy; prostaglandin; prostamide.

Figures

Figure 1
Figure 1
Study design. Abbreviation: IOP, intraocular pressure.
Figure 2
Figure 2
Mean IOP at each time point. Error bars, standard error of the mean. Abbreviation: IOP, intraocular pressure.
Figure 3
Figure 3
Mean change (A) and mean percentage change (B) in intraocular pressure from latanoprost baseline at each time point during follow-up. Error bars, standard error of the mean. *P≤0.035 versus bimatoprost 0.03%.
Figure 4
Figure 4
Percentage of patients achieving specific diurnal intraocular pressures at week 12. *P≤0.041 versus bimatoprost 0.03%. Abbreviation: IOP, intraocular pressure.
Figure 5
Figure 5
Severity of conjunctival hyperemia on biomicroscopic examination. (A) Mean severity scores. (B) Change from latanoprost-treated baseline in the percentage of patients with mild or greater severity of conjunctival hyperemia. Error bars, standard error of the mean.

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