Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy
ABSTRACT Fixed combinations of 0.2% brimonidine-0.5% timolol and 2% dorzolamide-0.5% timolol are used to lower intraocular pressure (IOP). The objective of this study was to evaluate the IOP-lowering efficacy and ocular tolerability of brimonidine-timolol compared with dorzolamide-timolol when used as monotherapy or as adjunctive therapy to a prostaglandin analog (PGA) in patients with glaucoma or ocular hypertension.
Pooled data analysis of two randomized, investigator-masked, 3-month, parallel-group studies with identical protocols (ten sites). In all, 180 patients with open-angle glaucoma or ocular hypertension who were in need of lower IOP received topical brimonidine-timolol BID or dorzolamide-timolol BID as monotherapy (n = 101) or as adjunctive therapy to a PGA (latanoprost, bimatoprost, or travoprost) (n = 79).
The studies are registered with the identifiers NCT00822081 and NCT00822055 at http://www.clinicaltrials.gov.
IOP was measured at 10 a.m. (peak effect) at baseline and at months 1 and 3. Tolerability/comfort was evaluated using a patient questionnaire.
There were no statistically significant between-group differences in patient demographics. Most patients were Caucasian, and the mean age was 68 years. There were also no statistically significant differences between treatment groups in baseline IOP. At month 3, the mean (SD) reduction from baseline IOP for patients on fixed-combination monotherapy was 7.7 (4.2) mmHg (32.3%) with brimonidine-timolol versus 6.7 (5.0) mmHg (26.1%) with dorzolamide-timolol (p = 0.040). The mean reduction from PGA-treated baseline IOP for patients on fixed-combination adjunctive therapy was 6.9 (4.8) mmHg (29.3%) with brimonidine-timolol versus 5.2 (3.7) mmHg (23.5%) with dorzolamide-timolol (p = 0.213). Patients on brimonidine-timolol reported less burning (p < 0.001), stinging (p < 0.001), and unusual taste (p < 0.001) than patients on dorzolamide-timolol.
Fixed-combination brimonidine-timolol provided the same or greater IOP lowering compared with fixed-combination dorzolamide-timolol. Both fixed-combination medications were safe and well-tolerated. Brimonidine-timolol received higher ratings of ocular comfort than dorzolamide-timolol. The duration of the studies was 3 months, and additional studies will be needed to compare the efficacy and tolerability of brimonidine-timolol and dorzolamide-timolol during long-term treatment.
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ABSTRACT: Abstract Purpose: To compare the efficacy and safety of bimatoprost 0.01% with the fixed combination travoprost 0.004%/timolol 0.05% in subjects with stable intraocular pressure (IOP) control on latanoprost and timolol. Methods: This was a randomized, prospective, investigator masked, crossover study comparing bimatoprost 0.01% with travoprost/timolol in 40 subjects diagnosed with primary open-angle glaucoma. Subjects were randomized to bimatoprost 0.01% qpm or travoprost/timolol qam and followed for 12 weeks, at which time they were crossed over to the alternate medication and followed for another 12 weeks. Intraocular pressure and hyperemia (rated on a standardized, 5-point photographic scale) were evaluated as change from baseline to 12 weeks following each therapy, and subject preference was elicited at the end of the study. Results: Both treatments were well tolerated and the majority of patients achieved effective IOP control relative to baseline. After 12 weeks of treatment, mean reductions from baseline IOP were -1.68 mmHg OD (right eye) and -1.58 mmHg OS (left eye) with bimatoprost and -0.45 mmHg OD and -0.53 mmHg OS with travoprost/timolol, although the differences between drugs were not statistically significant. Hyperemia scores were significantly higher with the fixed combination of travoprost/timolol than bimatoprost 0.01% as measured at 8 am (both P<0.01). Subject preference at the end of the study was more than 3 to 1 in favor of bimatoprost, with most citing greater tolerability. Conclusion: Bimatoprost 0.01% and travoprost/timolol are both effective at reducing IOP in subjects with stable IOP control on latanoprost and timolol, but bimatoprost 0.01% is associated with less hyperemia.Journal of ocular pharmacology and therapeutics: the official journal of the Association for Ocular Pharmacology and Therapeutics 09/2013; DOI:10.1089/jop.2013.0108 · 1.42 Impact Factor
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ABSTRACT: Purpose To evaluate the effect of treatment for 3 years with a dorzolamide/timolol (1%/0.5%) fixed combination (DTFC) on visual field progression in patients with open-angle glaucoma. Participants A total of 14 consecutive patients were enrolled who had been previously treated with monotherapy or any combination of a beta blocker, carbonic anhydrase inhibitor, and/or prostaglandin analog for primary open-angle glaucoma (POAG; n=4) or normal-tension glaucoma (NTG; n=10). Methods Patients were switched to DTFC from their prior glaucoma therapy. The IOP was measured at intervals of 4–6 weeks, and the visual fields were examined at least twice a year for 3 years. The annual change of mean deviation (MD slope) was used to quantify visual field loss. Results The mean MD value was −5.9±5.0 dB at baseline; it was −5.6±4.8 dB at 12 months, −5.9±5.0 dB at 24 months, and −5.6±5.1 dB at 36 months after switching. The mean MD slope was −0.2±0.8 dB/year before switching and 0.3±1.3 dB/year from baseline to 1 year, −0.3±1.1 dB/year from 1–2 years, and 0.3±0.9 dB/year from 2–3 years after switching. The mean MD slope from baseline to 36 months was correlated with the IOP reduction rate at 36 months after switching. Visual field progression was associated with the IOP reduction rate at 12 months after switching. Conclusion Switching to DTFC from prior glaucoma therapy improved the MD slope for at least 3 years. Reduction of the IOP after switching to DTFC was effective for delaying visual field progression. Although our study was not nonrandomized and was small in scale, the findings suggest that DTFC might have a beneficial effect on the visual fields in patients with open-angle glaucoma.Clinical ophthalmology (Auckland, N.Z.) 08/2014; 8:1579-90. DOI:10.2147/OPTH.S71162
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ABSTRACT: AIM: To evaluate intraocular pressure (IOP)-lowering effect and ocular tolerability of brimonidine/timolol, dorzolamide/timolol and latanoprost/timolol fixed combination therapies in the management of primary open angle glaucoma. METHODS: Each drug was administered for two months, after which a circadian tonometric curve was recorded using a Goldmann applanation tonometer. Ocular discomfort (conjunctival hyperemia, burning or stinging, foreign body sensation, itching, ocular pain) of each eye was assessed by the subject on a standardized ocular discomfort scale. RESULTS: Among the three study groups, there were no significant,differences in the mean baseline IOP measurements, mean 2nd mo IOP measurements, and mean (%) change of IOPs from baseline. Among the three study groups, there were no significant differences in the mean IOP measurements obtained at circadian tonometric curves at baseline and at two months controls. In sum brimonidine/timolol, dorzolamide/timolol and latanoprost/timolol fixed combination therapies showed similar effects on IOP levels. CONCLUSION: Brimonidine/timolol, dorzolamide/timolol and latanoprost/timolol fixed combination therapies showed similar lowering efficaties on IOP levels whereas there was no any difference between each other.International Journal of Ophthalmology 10/2014; 7(5):832-6. DOI:10.3980/j.issn.2222-3959.2014.05.17 · 0.12 Impact Factor