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Joao F. Lopes, Douglas A Hubatsch; Efficacy and Tolerability of BAK-Free Travoprost in Patients With Open-Angle Glaucoma Previously on Latanoprost. Invest. Ophthalmol. Vis. Sci. 2014;55(13):550.
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To assess the efficacy and tolerability of benzalkonium (BAK)-free travoprost in patients with open-angle glaucoma or ocular hypertension who were previously on latanoprost monotherapy.
This 12-week, multicenter, open-label, single-group study (NCT01510145) conducted in Argentina, Chile, and Colombia included patients ≥18 years with ocular hypertension or open-angle glaucoma in ≥1 eye who had been on latanoprost 0.005% monotherapy for ≥4 weeks before screening. Patients discontinued their latanoprost therapy and self-administered 1 drop of BAK-free travoprost 0.004% (preserved with polyquad) every evening at approximately 8 PM for 12 weeks. Assessments included change from baseline to week 12 in intraocular pressure (IOP), ocular surface health (assessed using the Ocular Surface Disease Index [OSDI], with scores ranging from 0 [no disability] to 100 [complete disability]), and ocular hyperemia (assessed from 0 [no hyperemia] to 3 [severe hyperemia]). Adverse events (AEs) and discontinuations due to AEs were reported.
191 patients were eligible for the study, and 173 patients completed the study. Mean IOP decreased by 5.4% from 14.8 mmHg at baseline to 13.8 mmHg at week 12 (P<0.001). The percentage of patients achieving the target IOP of ≤18 mmHg increased from 89.5% (171/191) at baseline to 93.3% (166/178) at week 12. From baseline to week 12, the mean OSDI score improved by 14.9% (decreasing from 22.2 to 13.7 mmHg; P<0.001). The mean ocular hyperemia score decreased from 0.94 at baseline to 0.74 at week 12. 42 AEs were reported in 15.2% (29/191) of patients. The most commonly reported AEs were eye irritation (3.7%), eye pruritus (3.1%), and eye pain (2.6%). Most AEs (31/42) were mild in severity, and there were no serious AEs. 6 patients discontinued from the study because of eye-related AEs.
BAK-free travoprost preserved with polyquad decreased IOP from baseline and was well tolerated over 12 weeks in patients with open-angle glaucoma or ocular hypertension who were previously on BAK-containing latanoprost.
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