Costa, Vital PaulinoMoreira, HamiltonPaolera, Mauricio DellaSilva, Maria Rosa Bet de Moraes [UNESP]2014-05-272014-05-272012-05-05Clinical Ophthalmology, v. 6, n. 1, p. 699-706, 2012.1177-54671177-5483http://hdl.handle.net/11449/73318Purpose: To assess the safety and efficacy of transitioning patients whose intraocular pressure (IOP) had been insufficiently controlled on prostaglandin analog (PGA) monotherapy to treatment with travoprost 0.004%/timolol 0.5% fixed combination with benzalkonium chloride (TTFC). Methods: This prospective, multicenter, open-label, historical controlled, single-arm study transitioned patients who had primary open-angle glaucoma, pigment dispersion glaucoma, or ocular hypertension and who required further IOP reduction from PGA monotherapy to oncedaily treatment with TTFC for 12 weeks. IOP and safety (adverse events, corrected distance visual acuity, and slit-lamp biomicroscopy) were assessed at baseline, week 4, and week 12. A solicited ocular symptom survey was administered at baseline and at week 12. Patients and investigators reported their medication preference at week 12. Results: Of 65 patients enrolled, 43 had received prior travoprost therapy and 22 had received prior nontravoprost therapy (n = 18, bimatoprost; n = 4, latanoprost). In the total population, mean IOP was significantly reduced from baseline (P = 0.000009), showing a 16.8% reduction after 12 weeks of TTFC therapy. In the study subgroups, mean IOP was significantly reduced from baseline to week 12 (P = 0.0001) in the prior travoprost cohort (19.0% reduction) and in the prior nontravoprost cohort (13.1% reduction). Seven mild, ocular, treatment-related adverse events were reported. Of the ten ocular symptom questions, eight had numerically lower percentages with TTFC compared with prior PGA monotherapy and two had numerically higher percentages with TTFC (dry eye symptoms and ocular stinging/burning). At week 12, TTFC was preferred over prior therapy for 84.2% of patients (48 of 57) by the patients themselves, and for 94.7% of patients (54 of 57) by their physicians. Conclusion: When TTFC replaced PGA monotherapy in patients whose IOP had been uncontrolled, the outcome was a significant reduction in IOP and an acceptable safety and tolerability profile. Most patients and investigators preferred TTFC to prior PGA monotherapy. © 2012 Costa et al, publisher and licensee Dove Medical Press Ltd.699-706engFixed combinationGlaucomaIntraocular pressureProstaglandin analogTimololTravoprostbenzalkonium chloridebimatoprosteye dropslatanoprostprostaglandin derivativetimolol plus travoprosttravoprostabnormal sensationadultadverse outcomeagedblepharitisclinical assessmentclinical effectivenesscontrolled clinical trialcontrolled studydisease controldose responsedrug efficacydrug hypersensitivitydrug safetydrug tolerabilitydrug withdrawaldry eyeevening dosageeye burningeye diseaseeye rednessfemalehumanintraocular hypertensionintraocular pressure abnormalitymajor clinical studymalemonotherapymulticenter studyocular pruritusopen angle glaucomaopen studyoutcome assessmentslit lamptreatment durationvisual acuityArtigo10.2147/OPTH.S30717Acesso aberto2-s2.0-848634336222-s2.0-84863433622.pdf5988776856320701