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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Comparative Analyses of Efficacy and Safety of Fixed Versus the Free Equivalent Combination of 1% Brinzolamide and 0.5% Timolol in Glaucoma Patients: A Prospective Observational Study

Author: TANVI AZMI, POOJA AGRAWAL, VIRENDRA KUSHWAHA, SHALINI MOHAN, AMIT KUMAR, HIMANSHU SHARMA
Abstract: Background: Present study was undertaken to analyse and compare the efficacy and safety of 1%Brinzolamide and 0.5% Timolol fixed-dose combination with its free equivalent combination in glaucoma patients at Tertiary Care Hospital. Method: It was a Prospective, Observational study. Patient were randomised into two group. Group-I patients received 1%Brinzolamide/0.5%Timolol fixed-dose combination and group-II patients received free equivalent combination of 1%Brinzolamide +0.5% Timolol. Patients were assessed for general and ocular examination on the day of enrolment and followed-up on 2, 4, 6, 8, and 12 weeks. For safety assessment adverse event related to drug were asked at each follow-up. Descriptive statistics were used to describe the variables mean±SD (standard deviation).p<0.05 was considered significant. Result: Significant reduction (p<0.001) in IOP from baseline 25.75±3.14mmHg to 17.6±1.58mmHg and from baseline 25.47±3.05 to 17.9±1.08mmHg at 12th week visit was observed with 1%Brinzolamide/0.5%TimololFDC and free equivalent combination of 1%Brinzolamide+0.5%Timolol respectively. On comparison between the groups, the mean reduction was not statistically significant (p>0.05). 8(40%) patients in 1%Brinzolamide/0.5%Timolol-FDC group and 13(65%) patients in 1%Brinzolamide+0.5%Timolol group reported ocular discomfort (Ocular Burning, Stinging, Ocular irritation, Ocular itching) Conclusions: Both fixed and free equivalent combination of 1%brinzolamide and 0.5% timolol are equivalent in reducing the intraocular pressure in glaucoma patients with lesser incidence of adverse events seen with 1%brinzolamide/0.5%timolol-FDC.FDCof 1%Brinzolamde/0.5%Timolol can be a better alternative to its free equivalent combination of 1%Brinzolamide+0.5% Timolol.
Keyword: 1%Brinzolamide/0.5%Timolol-FDC, Free equivalent 1%Brinzolamide+0.5%Timolol, Glaucoma.
DOI: https://doi.org/10.31838/ijpr/2021.13.02.188
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