Head To Head Comparasion of Topical Timolol (0.5%) + Bimatoprost (0.03%) Versus Topical Timolol (0.5%) + Dorzolamide (2%) In Primary Open-Angle Glaucoma

• Published in: The pharma innovation Vol. 5; no. 7, Part B; p. 86
• Main Authors: Chalivendra, Pallavi, Buchineni, Madhavulu, Muppa Singamma, Bhopal Chandra, Kudagi, B L, Pathapati, Rama Mohan
• Format: Journal Article
• Language: English
• Published: New Delhi The Pharma Innovation 01.07.2016
• Subjects: FDA approval; Glaucoma
• ISSN: 2277-7695

Primary open-angle glaucoma (POAG) is the second leading cause of blindness in the world, and third most common cause of blindness in India and its prevalence always increases with age. For larger intraocular pressure reduction, combination therapy with two drugs is required. To this purpose we compared the efficacy, safety and tolerability of fixed combination of topical Bimatoprost (0.03%) and Timolol (0.5%) with topical Dorzolamide (2%) and Timolol (0.5%) fixed combination in lowering intra ocular pressure in patients with primary open-angle glaucoma. This prospective randomised interventional study was conducted at a Medical college near Vijayawada over the period of 3 years. The total number of patients enrolled in this study was 60, and the number of patients in each treatment group was 30. After a thorough screening, one group was prescribed Timolol (0.5%) - Dorzolamide (2%) ophthalmic solution one drop twice daily, and similarly, the other group was prescribed Timolol (0.5%) - Bimatoprost (0.03%) ophthalmic solution one drop once daily in the morning. At each follow-up visit local and systemic adverse effects that occurred during the treatment period were recorded. Adverse effects were evaluated by asking patients a general query about their state of health. Patients were also queried regarding their compliance to the study medicine at each follow-up visit. Efficacy within the group is measured by comparing the mean IOP of each follow-up visit with the mean IOP of baseline visit in the same treatment group (either T-D/ T-B) and comparing both the significance in the difference of both the means by Student’s t- test (paired t-test). Efficacy between the two treatment groups is measured by comparing the mean IOP of both the treatment groups ( T-D & T-B) at each visit starting from visit 0 (baseline) and comparing the significance of the difference between the means of two groups by Student's t- test (Unpaired t-test). Safety is assessed by calculating the percent incidence of each adverse effects of each preparation. Tolerability is assessed by measuring the compliance of patients in each treatment group. Total 55 patients, clinically diagnosed with POAG were analysed in detail for the effect of above-fixed drug combination medications, at the end of 12 weeks. At 12 weeks, the mean IOP value for both the treatment groups is as follows: -p-value of paired t-test at 12 weeks for the T-D group is 0.002 (p<0.01), which is highly statistically significant. P value for the T-B group is 0.002 (p<0.01), which is also highly statistically significant. The p-value of unpaired t-test between two treatment groups at 12 weeks is 0.0007 (p<0.001), which is highly statistically significant. Hence, Timolol+Bimatoprost fixed combination was more efficacious and safe compared to Timolol+Dorzolamide fixed combination in the treatment of primary open-angle glaucoma