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S. Sonty, E. D. Sharpe, J. C. Henry, M. J. Weiss, J. A. Stewart, L. A. Nelson, W. C. Stewart; Success of Switching to Dorzolamide/Timolol Maleate Fixed Combination in Patients Who Are Insufficiently Controlled by Latanoprost Monotherapy and Who Are Timolol Maleate Responders. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5564.
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To assess the safety and efficacy of patients with ocular hypertension or open-angle, glaucoma who were switched to dorzolamide/timolol maleate fixed combination (DTFC) because they were insufficiently controlled on latanoprost monotherapy and who were timolol maleate responders.
A prospective, open-label cohort with an active-historical control study in which patients treated with latanoprost monotherapy for at least four weeks, who were considered to have insufficiently controlled intraocular pressure (IOP) and demonstrated an IOP of ≥ 19 mm Hg at 8 AM, were given a single test drop of timolol maleate in one randomly chosen eye. Patients were enrolled in the study if the eye dosed with timolol maleate demonstrated a decrease in IOP, two hours post dosing, of ≥ 3 mm Hg or ≥ 15%. Patients then were begun on DTFC dosed at 8 AM and 8 PM and their latanoprost was discontinued. Patients returned at Week 4 and Week 12 for IOP and safety evaluations.
Twenty-nine patients completed this study. After being switched to DTFC the IOP was further reduced by -2.7 ± 3.0 to 19.4 ± 3.6 mm Hg at 8 AM (P < 0.0001) and by -3.7 ± 3.0 to 17.3 ± 3.1 mm Hg at 10 AM by intent-to-treat analysis (P < 0.0001). Of the 22 reported ocular adverse events the most common were burning upon instillation (n = 11, 37%), conjunctival hyperemia (n = 3, 10%) and dry eyes (n = 3, 10%). Of the nine reported systemic adverse events the most common were unusual taste (n = 3), nausea (n = 2) and nose bleed (n = 2). Two patients were discontinued due to burning upon instillation (n = 1) and steroid use (n = 1).
This study suggests that patients who are insufficiently controlled on latanoprost monotherapy and who are timolol maleate responders can achieve further reduction of IOP when switched to DTFC.
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