TY - JOUR AU - C. R., Jayanthi AU - R. N., Divyashree AU - B. L., Sujatha PY - 2017/08/22 Y2 - 2024/03/28 TI - Efficacy and safety of topical BAK-free travoprost 0.004% versus BAK-preserved travoprost 0.004% in the treatment of primary open angle glaucoma: a comparative study at a tertiary care hospital JF - International Journal of Basic & Clinical Pharmacology JA - Int J Basic Clin Pharmacol VL - 6 IS - 9 SE - Original Research Articles DO - 10.18203/2319-2003.ijbcp20173744 UR - https://www.ijbcp.com/index.php/ijbcp/article/view/1879 SP - 2199-2205 AB - <p><strong>Background: </strong>Prostaglandin analogues (PGAs) reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG); however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK). Hence the above study was taken to evaluate the benefit of BAK-free formulations of travoprost. The objectives of the study were to compare the efficacy, safety of topical BAK-free travoprost 0.004% versus BAK-preserved travoprost 0.004% in patients with primary open angle glaucoma.</p><p><strong>Methods:</strong> 40 patients with POAG who fulfilled the inclusion /exclusion criteria were randomised into two groups of 20 each to receive BAK-free travoprost 0.004% or BAK-preserved travoprost once daily in the evening. Efficacy was measured in terms of reduction in IOP monitored at 4, 8 and 12 weeks from baseline. Ocular surface disease index (OSDI) questionnaire was used to assess the ocular surface symptoms. Safety was assessed by monitoring treatment emergent adverse drug reactions (ADRs).</p><p><strong>Results:</strong> Both the study medications were effective in reducing IOP when compared to baseline. Mean IOP reduction from baseline to week 12 was 11±3mmHg (p &lt;0.001), 10.78±3.01mmHg, (p&lt;0.001) in BAK-free travoprost and BAK-preserved travoprost groups respectively. Both produced equivalent reductions in IOP at the end of 4 (7.89±1.82 vs 7.63±2.83, p=0.72), 8 (9.94±2.75 vs10.05±2.75, p=0.90), and 12 weeks (11±3 vs10.78±3.01, p=0.82). BAK-free travoprost demonstrated significantly lower OSDI scores (15.10±3.60) compared to BAK- preserved travoprost (23.47±7.10) at 12 weeks (p &lt;0.0001). There was no significant difference in occurrence of conjunctival hyperaemia between the study drugs (c<sup>2</sup> = 0, df = 1, p = 1) and BAK-free travoprost was well tolerated.</p><p><strong>Conclusions:</strong> BAK-free and BAK-preserved travoprost significantly reduced IOP at 12 weeks. But, BAK- free travoprost produced significantly less ocular surface symptoms as compared to BAK- preserved travoprost. Hence it could be a favourable option in POAG patients with ocular surface disease symptoms.</p> ER -