Abstract
Purpose: :
To evaluate open-angle glaucoma patients, who were insufficiently controlled on latanoprost monotherapy, to determine the 24-hour intraocular pressure (IOP) efficacy and safety when changing them to dorzolamide/timolol (DTFC) or latanoprost/timolol fixed combination (LTFC) or adding DTFC.
Methods: :
Qualified primary open-angle or exfoliative glaucoma patients with a baseline IOP > 21 mm Hg on latanoprost monotherapy were randomized 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-hour IOP monitoring.
Results: :
Thirty-one completed this study. The mean 24-hour baseline IOP on latanoprost was 22.1 ± 3.5 mm Hg. All 3 adjunctive therapies significantly reduced the IOP at each time point and for the mean 24-hour curve, except at 18:00 and 02:00 with DTFC and 02:00 with LTFC. No statistical differences were found between DTFC (19.9 ± 3.2 mm Hg) and LTFC (19.5 ± 3.1 mm Hg) in a pairwise comparison (P > 0.39). The addition of DTFC to latanoprost provided the lowest mean 24-hour IOP (16.5 ± 2.8 mm Hg) versus latanoprost monotherapy (P < 0.0001) and the lowest IOP at each individual time point (P < 0.0032). However, there was no difference between all therapies for 24-hour IOP fluctuation (P = 0.31). All treatments were well tolerated but DTFC and latanoprost showed more burning/stinging (P = 0.002).
Conclusions: :
This study showed DTFC, LTFC and the addition of DTFC to latanoprost significantly decrease the IOP compared to latanoprost alone, but the latter therapy regime obtains the greatest IOP reduction.
Clinical Trial: :
www.clinicaltrials.gov NCT00397241
Keywords: intraocular pressure • drug toxicity/drug effects • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials