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.

Long-term cost and efficacy analysis of latanoprost versus timolol in glaucoma patients in Germany.

AIM: To evaluate 5-year effectiveness and cost between latanoprost or timolol monotherapy in a pilot trial. METHODS: A retrospective, multi-center trial performed at 6 sites in Germany of patients who had a diagnosis of primary open-angle or pigmentary glaucoma, in at least one eye, initiated on monotherapy with latanoprost or timolol maleate. Qualified consecutive charts were reviewed in which 5-year efficacy, safety and cost data was abstracted. RESULTS: Seventy-seoen latanoprost and 49 timolol patients were included, at the final visit no difference existed between the two groups in disc parameters including: rim area, rim area/disc area ratio, cup volume or vertical cup/disc ratio (P>0.05). There was no difference in intraocular pressure (IOP) between the initial latanoprost (17.4±2.6) and timolol (16.3±2.8mmHg) groups. There was less change in medicines over the follow-up period (0.1 vs 0.8) and fewer medications at the final visit (1.2 vs 1.8) with latanoprost compared to timolol. No patient treated with latanoprost discontinued therapy during follow-up, while 12% discontinued timolol mostly due to inadequate IOP control. Cost/year was less with initial timolol ($458±236) as compared to latanoprost ($552±202). CONCLUSION: Patients begun on latanoprost or timolol and followed over 5 years may have similar clinical outcomes. However, timolol patients may require more medicines and medicine changes to control IOP for long-term, but at a lower cost.

Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension.

BACKGROUND: Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice. METHODS: Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10-14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians' discretion. RESULTS: Bimatoprost 0.01% significantly lowered mean IOP from baseline by -4.1 mmHg (P < 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by -6.5 mmHg (P < 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of ß-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment. CONCLUSION: Bimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.

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.

Midterm response with latanoprost therapy in german ocular hypertension patients.

PURPOSE: The purpose of this prospective observational trial was to report the analysis of the midterm efficacy, safety, and discontinuation rates of a cohort of ocular hypertensive patients treated with latanoprost in Germany. METHODS: A subanalysis of patients with ocular hypertension who were previously treated on latanoprost monotherapy and continued within the study on this same medication for at least 6 months. RESULTS: 353 patients with ocular hypertension were included and treated with latanoprost monotherapy historically (1.4 +/- 1.3 years) and within the observational period of the study for a mean of 2.2 +/- 1.1 years. On latanoprost only, the average intraocular pressure at study entry was 18.4 +/- 2.7 mm Hg, and at 6 months the intraocular pressure was 18.3 +/- 2.3 mmHg (p = 0.54). During the observational period, the most common ocular side effect was conjunctival hyperemia (20.7%), and the most common systemic side effect was fatigue (3.1%). Nineteen patients (5.4%) discontinued latanoprost with the most common reason being insufficient efficacy (3.1%). Physician assessments of latanoprost monotherapy were "very good" to "excellent" for patient efficacy (75.2%), tolerability (83.8%), and patient satisfaction (82.1%). CONCLUSIONS: The study suggests that patients with ocular hypertension already treated with latanoprost monotherapy will continue to have, on average, at least midterm stable pressures, low incidence of side effects and discontinuations, as well as "very good" to "excellent" physician ratings of efficacy, tolerability, and patient satisfaction.