Objective: To evaluate open-angle glaucoma patients, who were insufficiently controlled on latanoprost monotherapy, to determine the 24 h intraocular pressure (IOP) efficacy and safety when changing them to dorzolamide/timolol (DTFC) or latanoprost/timolol fixed combination (LTFC) or adding DTFC.
Methods: A prospective, observer-masked, placebo-controlled, crossover, comparison. Consecutive adults with primary open-angle or exfoliative glaucoma who exhibit a mean baseline IOP >21 mm Hg on latanoprost monotherapy were randomised for 3 months to: DTFC, LTFC or DTFC and latanoprost. Patients were then crossed over to the next treatment for periods 2 and 3. At the end of the latanoprost run-in and after each 3-month treatment period, patients underwent 24 h IOP monitoring.
Results: 31 patients completed this study. All three adjunctive therapies significantly reduced the IOP at each time point and for the mean 24 h curve, except at 18:00 and 02:00 with DTFC and 02:00 with LTFC. When the three treatments were compared directly, the DTFC and latanoprost therapy demonstrated lower IOPs versus the other treatment groups, including: the mean 24 h pressure, maximum as well as minimum levels and individual time points following a modified Bonferroni correction (p<0.0032).
Conclusions: This study showed DTFC, LTFC and the addition of DTFC to latanoprost significantly decrease the IOP compared with latanoprost alone, but the latter therapy regime yields the greatest IOP reduction.
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Funding: The clinical site was supported in part by an unrestricted grant from Merck. The administrative site, PRN Pharmaceutical Research Network, LLC, received no financial support for this study.
Competing interests: AGP Konstas has received research funding and honoraria from Alcon, Allergan, Merck and Pfizer.
Ethics approval: Ethics approval was provided by the Bioethics Committee of the Medical School, Aristotle University of Thessaloniki.
Patient consent: Obtained.