An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial
Donald R Nixon,1 Susan Simonyi,2 Meetu Bhogal,2 Christopher S Sigouin,3 Andrew C Crichton,4 Marino Discepola,5 Cindy ML Hutnik,6 David B Yan71Private Practice, Barrie, ON, 2Allergan Inc, Markham, ON, 3CLINWest Research, Burlington, ON, 4University of Calgary, Calgary, AB, 5McGill University, Montrea...
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Dove Medical Press
2012
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oai:doaj.org-article:560bc23287da429d94e43a951979f51c2021-12-02T04:54:08ZAn observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial1177-54671177-5483https://doaj.org/article/560bc23287da429d94e43a951979f51c2012-12-01T00:00:00Zhttp://www.dovepress.com/an-observational-study-of-bimatoprost-001-in-treatment-naiumlve-patien-a11787https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Donald R Nixon,1 Susan Simonyi,2 Meetu Bhogal,2 Christopher S Sigouin,3 Andrew C Crichton,4 Marino Discepola,5 Cindy ML Hutnik,6 David B Yan71Private Practice, Barrie, ON, 2Allergan Inc, Markham, ON, 3CLINWest Research, Burlington, ON, 4University of Calgary, Calgary, AB, 5McGill University, Montreal, QC, 6London Health Sciences Centre, London, ON, 7University of Toronto, Toronto, ON, CanadaBackground: This study was designed to evaluate the occurrence and severity of ocular hyperemia in subjects with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) following treatment with bimatoprost 0.01% in a real-world clinical setting.Methods: This was an open-label, observational study conducted at 67 centers in Canada. Subjects with elevated IOP due to POAG or OHT instilled bimatoprost 0.01% topically as monotherapy once daily. Ocular hyperemia was graded by the investigator at baseline and weeks 6 and 12 using a photographic five-point grading scale. Change in IOP from baseline was also evaluated at these time points. This analysis includes only the subgroup of 522 subjects who were naïve to IOP-lowering medication prior to the study.Results: After 12 weeks of treatment with bimatoprost 0.01%, hyperemia was graded as none-to-mild (grades 0, +0.5, or +1) for 93.3% of subjects and as moderate-to-severe (grades +2 or +3) for 6.7%. At weeks 6 and 12, most subjects (93.2% and 93.5%) had no change in hyperemia grade from baseline. IOP was reduced by 7.4 mmHg (29.8%) at week 6 and 7.7 mmHg (30.9%) at week 12 from baseline.Conclusion: This real-world, observational study found that bimatoprost 0.01% instilled once daily reduced IOP by a mean of 30% from baseline without moderate or severe ocular hyperemia in 93% of treatment-naïve subjects with POAG or OHT.Keywords: glaucoma, intraocular pressure, hyperemia, bimatoprostNixon DRSimonyi SBhogal MSigouin CSCrichton ACDiscepola MHutnik CMLYan DBDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2012, Iss default, Pp 2097-2103 (2012) |
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Ophthalmology RE1-994 |
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Ophthalmology RE1-994 Nixon DR Simonyi S Bhogal M Sigouin CS Crichton AC Discepola M Hutnik CML Yan DB An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial |
| description |
Donald R Nixon,1 Susan Simonyi,2 Meetu Bhogal,2 Christopher S Sigouin,3 Andrew C Crichton,4 Marino Discepola,5 Cindy ML Hutnik,6 David B Yan71Private Practice, Barrie, ON, 2Allergan Inc, Markham, ON, 3CLINWest Research, Burlington, ON, 4University of Calgary, Calgary, AB, 5McGill University, Montreal, QC, 6London Health Sciences Centre, London, ON, 7University of Toronto, Toronto, ON, CanadaBackground: This study was designed to evaluate the occurrence and severity of ocular hyperemia in subjects with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) following treatment with bimatoprost 0.01% in a real-world clinical setting.Methods: This was an open-label, observational study conducted at 67 centers in Canada. Subjects with elevated IOP due to POAG or OHT instilled bimatoprost 0.01% topically as monotherapy once daily. Ocular hyperemia was graded by the investigator at baseline and weeks 6 and 12 using a photographic five-point grading scale. Change in IOP from baseline was also evaluated at these time points. This analysis includes only the subgroup of 522 subjects who were naïve to IOP-lowering medication prior to the study.Results: After 12 weeks of treatment with bimatoprost 0.01%, hyperemia was graded as none-to-mild (grades 0, +0.5, or +1) for 93.3% of subjects and as moderate-to-severe (grades +2 or +3) for 6.7%. At weeks 6 and 12, most subjects (93.2% and 93.5%) had no change in hyperemia grade from baseline. IOP was reduced by 7.4 mmHg (29.8%) at week 6 and 7.7 mmHg (30.9%) at week 12 from baseline.Conclusion: This real-world, observational study found that bimatoprost 0.01% instilled once daily reduced IOP by a mean of 30% from baseline without moderate or severe ocular hyperemia in 93% of treatment-naïve subjects with POAG or OHT.Keywords: glaucoma, intraocular pressure, hyperemia, bimatoprost |
| format |
article |
| author |
Nixon DR Simonyi S Bhogal M Sigouin CS Crichton AC Discepola M Hutnik CML Yan DB |
| author_facet |
Nixon DR Simonyi S Bhogal M Sigouin CS Crichton AC Discepola M Hutnik CML Yan DB |
| author_sort |
Nixon DR |
| title |
An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial |
| title_short |
An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial |
| title_full |
An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial |
| title_fullStr |
An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial |
| title_full_unstemmed |
An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial |
| title_sort |
observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the clear trial |
| publisher |
Dove Medical Press |
| publishDate |
2012 |
| url |
https://doaj.org/article/560bc23287da429d94e43a951979f51c |
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