Safety and Efficacy for the combination of Brimonidine and Timolol in patients for the treatment of Glaucoma

Abstract

Introduction:

Glaucoma is a prevalent neurodegenerative disorder of the eye which can be characterised by increased intraocular pressure which leads to chronic, degenerative optic neuropathy. Fixed dose combination of Brimonidine 0.2%w/v and Timolol 0.5%w/v per ml can be used for the treatment of glaucoma due to elevated intraocular pressure (IOP).

Methodology:

Of total 150 enrolled patients, 125 patients completed the study and of 125 patients the clinical trial was conducted on 227 eyes. All the patients were asked to use the study fixed dose combination of Brimonidine 0.2%w/v and Timolol 0.5%w/v per ml twice a day. Efficacy assessment was done at visit 2 (day 10), visit 3 (day 20) and visit 4 (day 30) by analysing the reduction in the IOP as compared to baseline and safety assessment was done by recording and analysing the adverse events through the study.

Results:

At baseline the mean IOP was 27.659 which was decreased by 22.193% to 21.520 at visit 2 (V2), at visit 3 (V3) it was further decreased by 25.207% to 20.687 and at visit 4 (V4) the mean IOP was further decreased by 25.446% to 20.621.0. At V1 all 227 patients were having IOP>21 but at V2, V3 and V4; 134 (59.03%), 136 (59.91%) and 162 (71.36%) patients were having their IOP in the normal range i.e. IOP≤21.

Conclusion:

Fixed dose combination of Brimonidine 0.2%w/v and Timolol 0.5%w/v per ml is safe as well as efficacious for the treatment of glaucoma due to elevated IOP.