An observational study of bimatoprost 0.01% in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial

Abstract

Background

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

Acknowledgments

The authors acknowledge the writing assistance of Darryl C Baptiste, MBA, Ph.D. and the editorial assistance of Mary Ann Chapman, Ph.D. This study was supported by Allergan Inc., and is reported here on behalf of the CLEAR Study Group: Iqbal Ike K Ahmed, Mississauga, ON; Rama Behki, Gatineau, PQ; Robert Beldavs, Winnipeg, MB; Francois Bellefeuille, Trois-Rivieres, PQ; Dan Belliveau, Halifax, NS; Raj Bindlish, Oakville, ON; Fadi Calotti, Brantford, ON; Jeff Chambers, Kelowna, BC; Jason Cherry, Richmond, BC; Robert Chevrier, Gloucester, ON; Alan Coffey, Westmount, PQ; Andy Crichton, Calgary, AB; Marino Discepola, Montreal, PQ; Gordon Douglas, Calgary, AB; Stephane Dupont, Gramby, PQ; Chaim Edelstein, Montreal, PQ; Stephen Fichman, Montreal, PQ; Bryce Ford, Calgary, AB; Michel Giunta, Sherbrooke, PQ; Sheldon Goldhar, Scarborough, ON; Larry Green, Sidney, BC; Francine Guay, Lévis, PQ; Eugene Hladky, Montreal, PQ; Glen Hoar, Comox, BC; Muhammad Humayun, Dartmouth, NS; Cindy Hutnik, London, ON; Norman Hwang, Burnaby, BC; Fahim Ibrahim, Point Edward, ON; Carolyn Isbister, West Vancouver, BC; Helene Joyal, Saint-Jean-sur-Richelieu, PQ; Barry Kattleman, Montreal, PQ; Baseer Khan, Vaughan, ON; Elie Khouri, Saint-Laurent, PQ; Thomas Klein, Mississauga, ON; Alain Lachance, Saint-Georges, PQ; Hesham Lakosha, Halifax, NS; Alain Lamoureux, Sorel, PQ; Gisele Li, Montreal, PQ; Derek Lui, Woodstock, ON; Mark Lukasik, Owen Sound, ON; Sam Markowitz, Toronto, ON; Jean Mayer, St-Charles Borrome, PQ; Mohan Merchea, London, ON; Michael Miller, Mississauga, ON; Kam Mohaseb, North Vancouver, BC; Paul Murphy, Saskatoon, SK; Rashmi Nigam, Winnipeg, MB; Don Nixon, Barrie, ON; Patrick O’Keeffe, North Battleford, SK; Manuel Perrier, Lachine, PQ; Carl Peters, Penticton, BC; Theodore Rabinovitch, Downsview, ON; Aaron Rifkind, Hamilton, ON; Suleiman Sefau, Charlottetown, PE; Rob Semeniuk, Penticton, BC; Lesya Shuba, Halifax, NS; Barry Silver, Dorval, PQ; Zakaria Tadrous, Abbotsford, BC; Eric Tam, Brampton, ON; Alexander Tan, Halifax, NS; Andrew Taylor, Niagara Falls, ON; Patricia Teal, Fort Erie, ON; David Yan, Mississauga, ON; Natasha Yepes, Kitchener, ON.

Disclosure

Publication of this article was sponsored by Allergan Inc. Susan Simonyi and Meetu Bhogal are employees of Allergan Inc. Chris Sigouin is an employee of ClinWest, which received fees for assisting with statistical analysis. Drs. Donald R Nixon, Andrew C Crichton, Marino Discepola, Cindy ML Hutnik and David B Yan declare no potential conflicts of interest in this work.