Brinzolamide 1%/timolol versus dorzolamide 2%/timolol in the treatment of open-angle glaucoma or ocular hypertension: prospective randomized patient-preference study.

PURPOSE: The objective of this study was to assess preference for fixed-combination brinzolamide 1%/timolol 0.5% (BTFC) versus fixed-combination dorzolamide 2%/timolol 0.5% (DTFC) in patients with open-angle glaucoma or ocular hypertension. METHODS: In this prospective, single-masked crossover study, patients were randomized 1:1 to BTFC-DTFC or DTFC-BTFC treatment sequences. Patients self-administered each medication for 7 days, with a 48-hour washout period between treatments, and rated ocular discomfort after each treatment period. Medication preferences based on ocular comfort (primary endpoint) and anticipated adherence were assessed. Safety outcomes included adverse events and intraocular pressure. Between-group differences in treatment preference and ocular discomfort scores were analyzed using chi-square and Wilcoxon-Mann-Whitney tests, respectively. Adherence, intraocular pressure, and adverse events were summarized descriptively. RESULTS: In total, 112 patients were enrolled (mean ± SD age, 66±11 years), and 109 patients completed the study. Numerically, more patients in the intent-to-treat dataset preferred BTFC versus DTFC (59.3% versus 40.7%); however, this result was not statistically significant (treatment difference, 18.6%; P=0.0670). Mean ocular discomfort scores (range, 0-9) were statistically significantly lower with BTFC versus DTFC (2.6 versus 3.7; P=0.0002, Wilcoxon- Mann-Whitney test). More patients who preferred BTFC over DTFC were confident that they would adhere to their preferred medication. Treatment-related adverse events included blurred vision with BTFC and eye irritation or eye pain with DTFC. CONCLUSION: BTFC and DTFC were preferred by approximately 60% and 40% of patients, respectively, and BTFC was associated with less patient-reported ocular discomfort. Greater ocular comfort of glaucoma medications may improve treatment adherence.

Efficacy and safety of fixed-combination travoprost 0.004%/timolol 0.5% in patients transitioning from bimatoprost 0.03%/timolol 0.5% combination therapy.

PURPOSE: To determine the efficacy and safety of fixed-combination travoprost 0.004%/timolol 0.5% preserved with polyquaternium-1 in patients with insufficient response to bimatoprost 0.03%/timolol 0.5% preserved with benzalkonium chloride. PATIENTS AND METHODS: In this open-label nonrandomized study conducted at 13 European sites, patients with primary open-angle glaucoma or ocular hypertension with insufficient intraocular pressure (IOP) reduction during bimatoprost/timolol therapy were transitioned to travoprost/timolol (DuoTrav(®)) administered every evening for 12 weeks. Change in IOP from baseline to week 12 was assessed in patients who transitioned from fixed-combination bimatoprost/timolol (n=57, primary endpoint). Secondary assessments included change in IOP at week 4, percentage of patients with IOP ≤18 mmHg at weeks 4 and 12, change in Ocular Surface Disease Index and ocular hyperemia scores at week 12, and patient preference. Adverse events were also reported. RESULTS: IOP change (mean ± SD) from baseline to week 12 was -3.8±1.9 mmHg (P<0.001); results were similar at week 4. Most patients had IOP ≤18 mmHg at weeks 4 and 12 (78.6% and 85.5%, respectively). Mean Ocular Surface Disease Index score was significantly reduced (P<0.001); no significant change in ocular hyperemia score was observed (P=0.197). Treatment-related adverse events included dysgeusia, nausea, paresthesia, myalgia, headache, and eye irritation (n=1 each). Most patients (74.5%) preferred travoprost/timolol over bimatoprost/timolol. CONCLUSION: Transition to travoprost/timolol significantly reduced IOP and was well tolerated in patients who had elevated IOP despite bimatoprost/timolol therapy. Polyquaternium-1-preserved travoprost/timolol was preferred over prior treatment with benzalkonium chloride-preserved bimatoprost/timolol.

Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%.

INTRODUCTION: Patients with glaucoma or ocular hypertension who do not achieve target intraocular pressure (IOP) using one hypotensive agent are often transitioned to combination therapy. Travoprost 0.004%/timolol 0.5% fixed combination (TTFC) has shown efficacy in patients whose IOP is not controlled with other therapies. The goal of this study was to assess the efficacy and safety of transitioning to TTFC in patients whose IOP was uncontrolled on bimatoprost 0.03%/timolol 0.5%, administered concomitantly or as a fixed combination. METHODS: This was a prospective, open-label, multicenter study of patients with open-angle glaucoma or ocular hypertension who transitioned to TTFC from fixed or unfixed bimatoprost/timolol. Patients self-administered TTFC once daily for 8 weeks, and efficacy and safety were assessed at baseline, Week 4, and Week 8. A symptom survey was administered at baseline and Week 8. Both patients and investigators reported their medication preference at Week 8. RESULTS: A total of 105 patients were enrolled in the study. Mean IOP decreased by 16.5% from baseline after 8 weeks of TTFC therapy in the total population, 15.0% in patients transitioning from fixed-combination therapy, and 20.8% in patients transitioning from unfixed therapy (P<0.001 for all groups). The percentage of patients reaching target IOP (≤18 mmHg) after treatment with TTFC was 69.2% (P<0.001). Patients judged stinging/burning to be less severe with TTFC than with prior therapy (P=0.029); all other symptom frequencies and severities were similar for both treatments. Patients preferred TTFC over bimatoprost/timolol (fixed and unfixed) at a ratio of more than 4:1 (81.4% vs. 18.6%; P<0.001), and investigators reported a nearly five-fold preference for TTFC (83.3% vs. 16.7%; P<0.001). No unexpected safety concerns with TTFC were observed. CONCLUSION: Travoprost 0.004%/timolol 0.5% fixed combination produced a significant reduction in IOP, with favorable safety and tolerability profiles. Both patients and investigators strongly preferred TTFC to prior bimatoprost 0.03%/timolol 0.5% therapy.

Diurnal IOP-lowering efficacy and safety of travoprost 0.004% compared with tafluprost 0.0015% in patients with primary open-angle glaucoma or ocular hypertension.

PURPOSE: To compare the diurnal intraocular pressure (IOP)-lowering efficacy and safety of travoprost 0.004% and tafluprost 0.0015% administered to patients with primary open-angle glaucoma or ocular hypertension. METHODS: This was a randomized, double-masked, active-controlled, crossover design trial, in which patients were randomized to either travoprost or tafluprost monotherapy administered once daily in the evening for six weeks and then crossed over to the alternative treatment for another six weeks. Diurnal IOP was measured (8 am to 8 pm, every two hours) and a solicited symptom survey was administered at the end of both six-week periods, as was conjunctival hyperemia and visual acuity assessment, slit-lamp biomicroscopy, and adverse event solicitation. RESULTS: Fifty-one patients were randomized and 48 patients completed the study. The 12-hour mean diurnal IOP was significantly lower with travoprost therapy than with tafluprost therapy (P = 0.01), and a significantly lower IOP was also reported for travoprost at five of the seven individual time points (P < 0.05). Neither therapy produced a significant increase from baseline in any of the individual patient-reported symptom scores, except for hyperemia (P ≤ 0.01), which was increased with both treatments. Investigator-observed hyperemia was also increased from baseline with both therapies (P < 0.01), although the increase with travoprost therapy was significantly smaller than with tafluprost (P < 0.01). No additional safety concerns were noted from slit-lamp biomicroscopy or visual acuity results, and no difference was noted in patient-reported tolerability of the two medications. CONCLUSION: Travoprost 0.004% monotherapy produced lower diurnal IOP than tafluprost 0.0015% in patients with primary open-angle glaucoma or ocular hypertension and exhibited a similar safety profile.

Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy.

PURPOSE: To assess the safety and efficacy of changing to the travoprost/timolol fixed combination (TTFC) from other mono- or adjunctive therapies. PATIENTS AND METHODS: A prospective, open-label, observational cohort of primary open-angle glaucoma and ocular hypertensive patients whose intraocular pressure (IOP) was uncontrolled on prior therapy or was not on target. Patients were changed from prior mono- or adjunctive treatment at Day 0 to TTFC dosed every evening and underwent active treatment efficacy and safety evaluations at Week 12. RESULTS: In 474/522 (91%) patients who completed this trial an IOP (mm Hg) of 21.9 +/- 2.0 on prior treatment was reduced by TTFC at Month 3: from all prior treatments 5.6 +/- 2.6; from monotherapy 5.9 +/- 2.3; from adjunctive treatments 4.5 +/- 2.9; and from several of the most frequent individual treatments: timolol 5.7 +/- 2.2; latanoprost 6.3 +/- 2.6; and latanoprost/timolol fixed combination 4.4 +/- 1.9. Ocular hyperemia was the most frequent adverse effect (n = 21, 4%). Both patients and physicians preferred TTFC compared to all prior and common individual treatments. The solicited symptom survey showed, following a modified Bonferroni correction (alpha/5), a reduced incidence with TTFC of ocular pain (P = 0.01) while the prior medicine had a lower incidence of burning on instillation (P < 0.001). CONCLUSIONS: Changing patients from prior mono- or adjunctive therapy to TTFC can provide on average a further reduction in IOP while demonstrating a favorable safety profile and a high patient preference.