Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

Abstract

BackgroundBimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice.MethodsData were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10–14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians’ discretion.ResultsBimatoprost 0.01% significantly lowered mean IOP from baseline by −4.1 mmHg (P < 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by −6.5 mmHg (P < 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of β-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment.ConclusionBimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.

An observational study of bimatoprost 0.01% in treatment-na&iuml;ve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial

“…These results are also consistent with those of a European, open-label observational study of 0.01% bimatoprost, which found a 6.5 mmHg lowering of IOP in treatment-naïve subjects, accompanied by a low rate (2.5%) of ocular or conjunctival hyperemia 10. In contrast with the recent report by Pfennigsdorf et al,10 the data presented here enable a more detailed analysis of ocular hyperemia attributed to bimatoprost 0.01% monotherapy as first-line IOP-lowering therapy for POAG and OHT patients through inclusion of a standardized ocular hyperemia severity grading system and assessment of IOP-lowering efficacy across three study visits (ie, baseline and at weeks 6 and 12).…”

A Cross-Sectional Survey of the Association between Bilateral Topical Prostaglandin Analogue Use and Ocular Adnexal Features

“…Preliminary studies indicate that bimatoprost 0.01% has acceptable IOP efficacy and as bimatoprost 0.03% users are converted to the lower dose, it will be important to assess the effect of bimatoprost 0.01% on adnexal features [25], [26]. Furthermore, because the study is cross-sectional, we were not able to analyze the reversibility of ocular adnexal changes.…”

An observational study of bimatoprost 0.01% in patients on prior intraocular pressure-lowering therapy: the Canadian Lumigan&reg; RC Early Analysis Review (CLEAR) trial

“…In 2003, a multicenter study involving 411 patients demonstrated that latanoprost 0.005%, travoprost 0.004%, and bimatoprost 0.03% were comparable in their ability to lower IOP, although differences were found in associated rates of conjunctival hyperemia 15. A recent observational study found that subjects who were switched to bimatoprost 0.01% from either latanoprost 0.005%, travoprost 0.004% preserved with 0.015% BAK (original version), tafluprost, or bimatoprost 0.03% achieved an additional IOP decrease of 2.8 mmHg, 3.1 mmHg, 2.8 mmHg, or 1.0 mmHg, respectively 16. It should be noted that for both the report by Pfennigsdorf et al16 and the present analysis, travoprost preserved with BAK was available in Europe and Canada, as well as in Argentina, Brazil, Chile, China, Colombia, India, Malaysia, Mexico, Taiwan, and Venezuela.…”

“…A recent observational study found that subjects who were switched to bimatoprost 0.01% from either latanoprost 0.005%, travoprost 0.004% preserved with 0.015% BAK (original version), tafluprost, or bimatoprost 0.03% achieved an additional IOP decrease of 2.8 mmHg, 3.1 mmHg, 2.8 mmHg, or 1.0 mmHg, respectively 16. It should be noted that for both the report by Pfennigsdorf et al16 and the present analysis, travoprost preserved with BAK was available in Europe and Canada, as well as in Argentina, Brazil, Chile, China, Colombia, India, Malaysia, Mexico, Taiwan, and Venezuela. As a result, the total number of patients who switched to bimatoprost 0.01% from prior travoprost preserved with BAK was low relative to other prior IOP-lowering therapies included in our analysis, due to the discontinuation of the original version of travoprost partway through study enrollment.…”