The cost-effectiveness of bimatoprost,latanoprost and timolol in treatment of primary open angle glaucoma in five European countries

ABSTRACT

Objective: The objective of this cost-effectiveness analysis is to evaluate cost-effectiveness ratios of the intraocular pressure (IOP)-lowering agents bimatoprost, latanoprost and timolol in five major European countries: France, Germany, Italy, Spain and the UK.

Methods: The cost-effectiveness analysis is based on achievement of IOP targets between 13 and 18?mm Hg. Thus, the cost-effectiveness ratios express the costs of having one patient successfully achieving IOP target. The perspective of the analysis is that of the health care sector payer, including costs of medicine and costs of ophthalmologist visits. The time frame is first year of glaucoma treatment. Four treatment strategies are analysed: Timolol as first line with add-on latanoprost or bimatoprost if IOP targets are not met, and latanoprost and bimatoprost as first line with add-on timolol.

Results: In the UK, Spain, Italy and Germany the timolol first with add-on of bimatoprost is the least expensive treatment. This strategy dominates both strategies involving latanoprost (as add-on to timolol or as first line) in these four countries. The incremental cost-effectiveness ratio of bimatoprost first-line therapy versus timolol with add-on bimatoprost varies from each country and target (from £305 to €43 720 per patient). In France the timolol first line and latanoprost add-on is not dominated and is the cheapest alternative. The incremental cost-effectiveness ratio of timolol with add-on bimatoprost versus add-on latanoprost lies between £71 and €355 per patient depending on target (18 and 13?mm Hg, respectively).

Conclusion: First-line treatment of latanoprost is dominated in all countries. In four out of five countries the timolol first-line therapy with add-on latanoprost is also dominated. Based on this pharmacoeconomic analysis, the most costeffective strategy seems to be timolol first line with add-on bimatoprost if target is not met after 3 months.     

Analytic review of bimatoprost,latanoprost and travoprost in primary open angle glaucoma

ABSTRACT

Objective: The objective of this review was to evaluate different measures of efficacy of the intraocular pressure (IOP) lowering lipid class agents bimatoprost, latanoprost and travoprost in the treatment of primary open angle glaucoma. Study arms of timolol in trials including the above mentioned lipid class drugs were also included.

Methods: MEDLINE and EMBASE were searched for randomized clinical trials including one or more of the lipid class drugs bimatoprost, latanoprost and travoprost. The study results were pooled, and the simple, weighted IOP-lowering efficacy was compared among the lipid class drugs and timolol, where data were available. Efficacy parameters were reviewed, including mean reduction of IOP and percentage of patients achieving different levels of IOP.

Results: 161 articles were identified of which 42 were included in the analysis. A total of 9295 patients participated in the included trials. Based on all studies, timolol on average had a weighted mean IOP reduction of 22.2%, while latanoprost, travoprost and bimatoprost had a weighted mean IOP reduction of 26.7%, 28.7% and 30.3%, respectively. Analysis of target achievement to various IOP levels shows that bimatoprost seems more efficacious than latanoprost. The direct comparisons (head-to-head studies) also show that bimatoprost is the most efficacious treatment, however it is not conclusive whether latanoprost or travoprost is better in reducing IOP.

Conclusions: This review shows that bimatoprost seems to be the most efficacious treatment in lowering IOP. Head-to-head studies confirm this.     

Comparison of the efficacy and safety of travoprost with a fixed-combination of dorzolamide and timolol in patients with open-angle glaucoma or ocular hypertension

ABSTRACT

Purpose: The purpose of this study was to compare travoprost (TRAV; travoprost 0.004%) and the fixed-combination of dorzolamide/timolol (DTFC; dorzolamide 2.0%/timolol maleate 0.5%) ophthalmic solutions for reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma (OAG) or ocular hypertension (OHT).

Methods: This was a randomized single masked, study with parallel controls. The TRAV group (n = 29) dosed once daily at 9:00 PM while the DTFC group (n = 27) dosed twice daily at 9:00 AM and 9:00 PM. IOP was measured at baseline, and following 3 weeks and 6 weeks of treatment at 8:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM.

Results: Mean average IOP reductions from baseline during the course of the day were 7.5 (32.7%) and 7.1 (30.7%)?mmHg for TRAV and 4.8 (23.1%) and 4.5 (21.7%)?mmHg for DTFC at 3 weeks and 6 weeks, respectively. The greater IOP reduction for patients receiving TRAV was statistically significant at both the 3 and 6 week visits when averaged across all four time points (?p < 0.01). The two products were well-tolerated over the course of the 6 week study. Some factors such as taste perversion were reported more often in the DTFC group.

Conclusions: Travoprost monotherapy provided better efficacy in terms of IOP reduction and per-centage of IOP reduction compared to dorzolamide 2.0%/timolol maleate 0.5% fixed combination.     

A systematic review of the characteristics of randomised control trials featuring prostaglandins for the treatment of glaucoma*

ABSTRACT

Aim: To classify the comparative quantity and quality of the RCT evidence of pharmacological treatment for glaucoma.

Method: A systematic review of MEDLINE, EMBASE Cochrane CENTRAL and relevant conference proceedings was conducted up to March 2007. RCTs recruiting adults with primary open angle glaucoma (POAG) and/or ocular hypertension (OH) receiving any topical medication or placebo were included. RCTs containing a prostaglandin treatment arm were specifically considered.

Results: A total of 510 publications were identified. Of these, 181 studies had a prostaglandin treatment arm. The median study duration was 12 weeks (IQR 4–13) and 78% of included trials had a duration of 3 months or less. The four studies over 1 year in duration all included a latanoprost and timolol treatment arm. There was a lack of data on younger populations (median of the mean ages of included patients was 63.4 years [IQR: 61–66 years]). Caucasians constituted 79.6% of the studied population. Evidence by ethnicity as well as by co-morbidity, was scarce. The primary outcome for 92% of studies was IOP reduction; little was reported on other indicators. Most trials reported adverse events, with hyperaemia most commonly reported.

Conclusion: The RCT evidence base for glaucoma treatment is extensive. This systematic review is the first to consider the characteristics of all RCTs containing a prostaglandin arm. The majority of trials are of short duration and focus on IOP as the efficacy outcome. The limitations of this study are that only trials with a prostaglandin treatment arm are included and due to the large number of included trials only top line data were extracted.     

Comparison of morning versus evening dosing and 24-h post-dose efficacy of travoprost compared with latanoprost in patients with open-angle glaucoma

ABSTRACT

Objective: To compare the IOP-lowering efficacy of a.m.-dosed travoprost and latanoprost at 24-h post-dose.

Research design and methods: Open-angle glaucoma patients not naïve to prostaglandin therapy and currently controlled on p.m.-dosed (2100) latanoprost (n?=?21) or travoprost (n?=?30) had baseline IOPs measured at 0900. In a randomized, single-masked, crossover design, patients received travoprost (Travatan) or latanoprost (Xalatan) at 0900 for 4?weeks, then were crossed over to receive the second prostaglandin for another 4?weeks. Treatment IOP was measured at 0900 prior to morning dose at both 4 and 8?week visits. Patient dosing preference (a.m./p.m.) was surveyed on exit.

Main outcome measure: Intraocular pressure (IOP).

Results: The mean IOP in the first period when all patients were dosed in the evening was assessed 12?h after dosing at 09:00 and it was similar in the two treatment groups (mean?±?standard deviation: 17.9?±?2.7?mmHg for travoprost versus 17.7?±?2.5?mmHg for latanoprost, p?=?0.812). In the a.m.-dosing crossover comparison, the 24-h post-dose IOP was significantly lower (?p?<?0.001) on travoprost (16.9?±?3.1?mmHg) compared to latanoprost (18.6?±?3.3?mmHg). In the exit survey, 51% of patients preferred a.m.-dosing.

Conclusions: a.m.-dosed travoprost is superior to a.m.-dosed latanoprost by 1.7?mmHg at 24-h post-dose.     

马来酸噻吗洛尔与布林佐胺联合曲伏前列素治疗开角型青光眼和高眼压症临床研究

目的对比评价马来酸噻吗洛尔与布林佐胺联合曲伏前列素治疗开角型青光眼和高眼压症的临床疗效。方法将我院使用曲伏前列素单药治疗效果不佳的开角型青光眼与高眼压的76例患者分为S组和B组,S组38例(38眼)患者在曲伏前列素基础上合用马来酸噻吗洛尔治疗,B组38例(38眼)患者则合用布林佐胺治疗,于2周和1、3、6个月随访。对比观察两组治疗前后的平均眼压、昼夜眼压差、心率、血压和不良反应发生情况。结果两组患者在联合用药后2周和1、3、6个月平均眼压下降,与治疗前比较差异均有统计学意义(P<0.05),两组间差异无统计学意义(P>0.05);S组联合用药后6个月昼夜眼压差较B组大,两组差异有统计学意义(P<0.05);两组患者在联合用药前后血压均无明显变化(P>0.05);B组患者心率在联合用药前后无明显变化(P>0.05),S组患者心率则在随访6个月时出现明显心脏抑制(P<0.05);两组均未出现严重不良反应。结论马来酸噻吗洛尔与布林佐胺联合曲伏前列素治疗开角型青光眼和高眼压疗效显著,布林佐胺联合曲伏前列素用药相对更稳定、更安全。     

Concomitant administration of travoprost and brinzolamide versus fixed latanoprost/timolol combined therapy: three-month comparison of efficacy and safety

SUMMARY

Purpose: To compare the efficacy and safety of the concomitant administration of travoprost 0.004% once daily and brinzolamide 0.1% twice daily with those of a fixed combination of latanoprost 0.005%/timolol 0.5% once daily.

Research, design and methods: Forty-four patients with primary open-angle glaucoma or ocular hypertension with elevated IOP insufficiently responsive to monotherapy were randomly assigned to one of the two treatment groups: concomitant administration of travoprost 0.004% once daily and brinzolamide 0.1% twice daily (TB group: 22 patients) or latanoprost 0.005% plus timolol 0.5% once daily (LT group: 22 patients). Visits were undertaken at screening (current ocular hypotensive therapy was discontinued), baseline (randomization), and after 2 weeks, 1 month, 2 months and 3 months of therapy.

Main outcome measures: IOP was determined at 9 a.m., 12 p.m. and 4 p.m. at each study visit, and diurnal IOP was calculated as the mean of these recordings. Adverse events were recorded at each visit.

Results: IOP at the baseline visit was similar in both groups. Overall mean IOP was significantly lower in the TB as compared to the LT group after 1?month, 2?month and 3?month follow-up; only 9 a.m. measurements were significantly different, reaching a maximum difference (16.9 ± 0.9?mmHg vs 18.4 ± 1.8?mmHg, p < 0.001) at the 3?month check. The percentage of responders (IOP decrease ≥ 30%) was higher in the TB group. Both treatments were well tolerated and there were no cases of withdrawal from treatment.

Conclusions: Travoprost 0.004% and brinzolamide 0.1% concomitant therapy showed a greater efficacy than the fixed latanoprost 0.005%/timolol 0.5% combination in terms of absolute IOP decreases. Travoprost/brinzolamide therapy also offered the advantages of a greater percentage of responders.     

24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma*

ABSTRACT

Objective: To evaluate the 24-hour efficacy and tolerability of 2% dorzolamide/0.5% timolol fixed combination (DTFC) solution in open-angle glaucoma and ocular hypertension.

Research design and methods: Randomized, parallel, doublemasked, multicenter study. Patients with insufficiently controlled intraocular pressure (IOP≥22 mmHg) were randomized to DTFC (N=117) or timolol (N=115). IOP was measured at baseline, 6 weeks, and 8 weeks, with measurements taken at 6 p.m., 8 p.m., 10 p.m., 2 a.m., 6 a.m., 8 a.m., 10 a.m., and 2 p.m.

Main outcome measures: Statistically significant change in IOP from untreated baseline for DTFC at all hours at week 8. Secondary outcome measures included: IOP-lowering at week 6 at all individual time points, change from baseline to 8 weeks in mean daytime IOP (average of 8 a.m., 10 a.m., 2 p.m., 6 p.m., and 8 p.m. IOPs) and night-time IOP (10 p.m., 2 a.m., 6 a.m.), and comparison of DTFC with timolol after 8 weeks.

Results: Patients receiving DTFC had a statistically significant and clinically relevant reduction in IOP at week 8 compared with baseline at all eight time points (p<0.001). Significant IOP reductions were also seen at all time points at week 6 (p<0.001). DTFC significantly lowered mean daytime IOP and night-time IOP (p<0.001 for both). Timolol alone also significantly reduced IOP from baseline at 8 weeks for all diurnal time points, and mean daytime and night-time IOP (p<0.001 for all). Compared with timolol alone, there were significantly greater reductions with DTFC at 10 a.m. (p=0.003) and 2 p.m. (p=0.016), and for mean daytime IOP (p=0.025) at 8 weeks. Significant between-treatment differences were not observed at other time points. Both treatments were well-tolerated, with no differences observed in the safety profiles between the treatment groups.

Conclusions: Both DTFC and timolol provided significant IOP reduction over the entire 24-hour measurement period. timolol during the daytime, but not at night. Although this study was not designed or powered to compare DTFC and timolol, DTFC exhibited greater IOP-lowering than timolol during the daytime, but not at night.

Trial registration: ClinicalTrials.gov identifier: NCT00108017.     

Ocular hypotensive efficacy of travoprost in patients unsuccessfully treated with latanoprost

SUMMARY

Objective: To evaluate the efficacy of travoprost 0.004% monotherapy in patients unsuccessfully treated with latanoprost monotherapy.

Research design and methods: Open-label, non-comparative study conducted at US academic and private practice clinics in adult patients with ocular hypertension or primary open-angle glaucoma who required a change in therapy (due to either inadequate efficacy or safety issues) as judged by the investigator. Intraocular pressure (IOP) was measured at entry and 30?days later.

Main outcome measures: Mean change in intra-ocular pressure (mm Hg).

Results: Reported here are 488 per-protocol patients from 330 centers who were using latanoprost monotherapy prior to study entry, and who received travoprost monotherapy during the study. Patients had a mean age of 69?years, were approximately two-thirds Caucasian, 60% female, predominantly brown or blue eyes, and 91% were diagnosed as having primary open-angle glaucoma. The mean days in treatment were 31.9 ± 6.4. Mean IOP at study entry was 21.2?mm Hg. Following travoprost monotherapy, this was reduced by a mean of 3.2?mm Hg to 18?mm Hg (?p < 0.0001, paired t-test). There were 21 adverse events reported in the intent-to-treat (ITT) population for an incidence of 3.5%. There were some limitations to the current study including: no washout period, no control therapy, single IOP determinations at the beginning and the end of the study; patient compliance with the initial therapy was not measured, and the study was not masked. This study reflects a real-life situation of what a clinician can expect when he changes a patient from latanoprost monotherapy to travoprost monotherapy.

Conclusion: This study showed that travoprost provided a statistically and clinically significant reduction (?p < 0.0001) in IOP of 3.2?mm Hg for patients who had not been successfully treated with latanoprost monotherapy. The results of this trial demonstrate the potential benefit of using travoprost as a replacement therapy in order to ensure adequate IOP control.     

Intraocular pressure reduction with travoprost/timolol fixed combination,with and without adjunctive brinzolamide,in glaucoma

ABSTRACT

Objective: To investigate if combined intraocular pressure (IOP)-lowering medication with travoprost/timolol fixed combination and a carbonic anhydrase inhibitor, brinzolamide, is superior to both travoprost monotherapy and travoprost/timolol fixed-combination therapy in primary open-angle glaucoma and ocular hypertension.

Methods: Following a 4-week wash-out period and using 4-week long treatment periods, 20 primary open-angle glaucoma or ocular hypertension patients were treated with evening travoprost 0.004?%?, then switched to evening travoprost 0.004?%?/timolol 0.5?%?fixed combination, and finally the treatment was combined with adjunctive twice-daily brinzolamide 1?%?ophthalmic suspension. Both eyes were treated, but only one eye per patient (the eye with the higher mean diurnal IOP at baseline), was evaluated. IOP was measured at 8 a.m., 12 noon and 4 p.m. at baseline and at the end of each treatment period.

Results: Mean diurnal IOP (mean (SD)) at baseline was 28.5 (7.3) mmHg which decreased to 22.3 (6.3) mmHg on travoprost, 19.2 (3.4) mmHg on travoprost/timolol fixed combination and 17.3 (3.4) mmHg when the brinzolamide was added to the travoprost/timolol combination (ANOVA, contrast test, p?<?0.003 for all comparisons). The individual time point IOP values showed similar and significant stepwise differences.

Conclusion: Adjunctive brinzolamide medication provided further IOP decrease in patients receiving evening-dosed travoprost/timolol fixed combination. The travoprost/timolol fixed combination was significantly more effective in IOP reduction than travoprost monotherapy, which by itself induced a significant IOP decrease compared to the untreated baseline value. The results of this open label study suggest that combined therapy with travoprost/timolol fixed combination and brinzolamide is clinically useful for IOP-lowering in primary open-angle glaucoma and ocular hypertension.     

Changes in intraocular pressure following a switch from latanoprost monotherapy to latanoprost/timolol fixed combination therapy in patients with primary open-angle glaucoma or ocular hypertension: results from a clinical practice database

ABSTRACT

Aims: To assess the incremental change in intraocular pressure (IOP) levels in patients with primary open-angle glaucoma or ocular hypertension, insufficiently treated with topical ocular hypotensive monotherapy or combination therapy and changed to the latanoprost/timolol fixed-combination therapy (LTFC).

Methods: The glaucoma database of the Glasgow Royal Infirmary was reviewed retrospectively to identify patients ≥?18 years of age with primary open-angle glaucoma or ocular hypertension in at least one eye who had been switched to LTFC from a previous monotherapy or combination therapy. Ninety patients were identified, and 59 (66%) had changed to LTFC from latanoprost monotherapy (LM). The analysis focused on this subgroup because few patients were changed from any other single therapy. At least one documented patient visit following the change to LTFC was required. The within-subject difference in IOP levels (IOP on LM–IOP on LTFC) was calculated for each case, and the statistical significance of the mean change in IOP was analysed using a 2-sided Student's paired t-test with a 0.05 α level.

Results: The mean decrease in IOP after changing to LTFC from LM was 2.6?mmHg (95% confidence interval?=?1.6, 3.6), from 21.4 (SD?=?3.5) mmHg to 18.8 (SD?=?4.2) mmHg (p?=?0.002).

Conclusions: LTFC provides significant incremental IOP reduction in patients with primary open-angle glaucoma or ocular hypertension who require additional IOP reduction following treatment with LM.     

A comparison of the safety and intraocular pressure lowering of bimatoprost/timolol fixed combination versus latanoprost/timolol fixed combination in patients with open-angle glaucoma*

ABSTRACT

Purpose: To compare the efficacy and tolerability of a once daily evening dose of the latanoprost/timolol fixed combination (LTFC) with that of a once-daily evening dose of the bimatoprost/timolol fixed combination (BTFC) in patients with open-angle glaucoma with elevated intrao­cular pressure (IOP) insufficiently responsive to mono­therapy with prostaglandin analogues/prostamides.

Design: Prospective, randomized, evaluator masked, single-center study.

Participants: 36 patients with a diagnosis of open-angle glaucoma, with or without pseudoexfoliation, and inadequate control of IOP, insufficiently responsive to monotherapy with prostaglandin analogues/prostamides.

Main outcome measure: The primary end-points were the change in IOP at 9:00?am from baseline to week 4, and the difference between treatment groups in the mean diurnal IOP reduction from baseline to week 4.

Results: BTFC provided significantly greater mean diurnal IOP reduction [mean (standard deviation)] 2.8 (0.9)?mmHg, compared with LTFC 2.1 (0.6)?mmHg, p = 0.0214. Both treatments significantly reduced the IOP from baseline at each IOP time-point measured, p < 0.0001, and for the mean diurnal IOP; p = 0.0049 for the LTFC, and p < 0.0001 for the BTFC. There were no significant differences in average hyperemia scores among groups, 1.25 (0.5) vs. 1.62 (0.69), p = 0.3835, for the LTFC and the BTFC, respectively.

Conclusions: The results of this study showed a significantly higher IOP-lowering effect of a once-daily evening dose of the BTFC compared to that of a once-daily evening administration of the LTFC.     

Brinzolamide 1%/timolol 0.5%: safety and efficacy of a new fixed-combination IOP-lowering product for glaucoma

Abstract

Objective:

To provide a commentary on recent studies with the new IOP-lowering fixed-combination product brinzolamide 1%/timolol 0.5%.     

A cost-effectiveness analysis of immunotherapy with SQ allergen extract for patients with seasonal allergic rhinoconjunctivitis in selected European countries

ABSTRACT

Background: Seasonal allergic rhinoconjunctivitis can, for some people, reduce quality of life and the ability to cope with everyday tasks.

Scope: In this paper we investigate the cost-effective­ness of immunization therapy with Alutard SQ (ASQ) and compare the cost-effectiveness in countries where the therapy has been in use in order to assess the impact of national therapeutic practices on the results of health economic assessments. Data are obtained from a clinical trial carried out in 2001–2002. To evaluate the cost-effectiveness of immunization we have added data on resource use in Austria, Denmark, Finland, Germany, the Netherlands, and Sweden.

Findings: The computations result in cost-effectiveness ratios for allergen immunization between €10?000 and €20?000 per QALY even without provision for indirect costs, and achieving dominance in most countries where indirect costs have also been taken into account. The country comparisons show that the direct cost of administrating the up-dosing and maintenance differs considerably between countries, and that the cost of medical staff is substantial, constituting in most cases more than half of the direct costs of the immunization therapy.

Conclusion: The study shows that immunotherapy with SQ allergen extract is cost-effective in a wide range of national environments, and that cost-effectiveness differences by country are largely a result of different practices in the up-dosing phase.     

A Markov modelled pharmacoeconomic analysis of bimatoprost 0.03% in the treatment of glaucoma as an alternative to filtration surgery in Italy

ABSTRACT

Objective: Glaucoma is generally managed by decreasing the intraocular pressure (IOP) to a level believed to prevent further damage to the optic disc and loss of visual field. This may be achieved medically or surgically. The objective of this pharmacoeconomic analysis was to investigate the 4‐year costs of bimatoprost 0.03% (Lumigan) eye drops as an alternative to filtration surgery (FS) for glaucoma patients on maximum tolerable medical therapy (MTMT).

Research design and method: A Markov model was designed using effectiveness and resource use data from a randomized clinical trial and expert statements (Delphi panel). The RCT covered 83 patients on MTMT. The model compared bimatoprost with FS. In the bimatoprost model arm patients began treatment with bimatoprost. If target IOP (–20%) was not reached using medical therapy the patient proceeded with FS. In the FS model arm, FS was performed after the first ophthalmologist visit. Unit costs were obtained from an Italian chart and tariffs review (healthcare sector perspective).

Results: The RCT showed that 74.7% of the patients delayed the need for FS by 3 months. The Markov model forecasted that 64.2% of the patients could delay the need for FS by 1 year, and forecasted 34.0% could avoid FS after 4 years. The 4‐year cost per patient in the bimatoprost and FS arms was €3438 and €4194, respectively (incremental costs of €755). The major cost drivers for the bimatoprost arm were patients who needed combination therapy or FS if the target IOP was not reached. In the FS arm, the major cost drivers were the initial surgery costs and pressure-lowering medications used as add-on therapy after FS.

Conclusions: The analysis shows that in a 4‐year perspective bimatoprost is cheaper compared to FS. In addition, the postponement of FS associated with bimatoprost may have important implications for waiting list planning.     

Influence of switching to travoprost on intraocular pressure of uncontrolled chronic open-angle glaucoma patients compliant to previously-used topical medication

ABSTRACT

Objective: To investigate the influence of switching to travoprost on intraocular pressure (IOP) of chronic open-angle glaucoma (COAG) patients.

Research design and methods: Multicentre, open-label, non-comparative, 12‐week, phase IV study conducted at 10 academic and hospital centres in Hungary. Patients’ compliance to use of the pre-study medication was confirmed at a visit 10 days before the baseline measurements, and compliance was monitored throughout the study period.

Results: Of the 203 COAG patients three (1.48%) ceased travoprost medication due to ocular hyperaemia, and one subject was lost from follow-up. Self-reported compliance was optimal except for two patients. For the per-protocol analysis 197 patients were evaluable. IOP of the 37 per-protocol patients receiving additional travoprost medication decreased from 23.1 ± 3.2?mmHg (mean ± SD) to 17.3 ± 2.6?mmHg at week 12 (?p < 0.001). Switching the 121 per-protocol patients from latanoprost to travoprost IOP decrease from 20.8 ± 3.5?mmHg to 17.7 ± 2.4?mmHg (?p < 0.001). IOP of the 11 patients switched from topical non-selective beta-blockers to travoprost decreased from 20.1 ± 2.1?mmHg to 15.7 ± 1.5?mmHg (?p < 0.001). For the whole per-protocol population (n = 197) IOP decreased from 21.0 ± 3.4?mmHg to 17.4 ± 2.4?mmHg (?p < 0.001). Defining responders as having an IOP decrease > 2.0?mmHg or ≥ 5?mmHg at week 12, the responder rate was respectively 62.9% or 31% for the total study population; 86.5% or 54.1% when travoprost was added to the established therapy; 54.5% or 24.0% if latanoprost was switched to travoprost; and 90.9% or 36.4% for those who switched from beta-blockers.

Conclusion: Travoprost provided a clinically and statistically significant IOP decrease in uncontrolled COAG patients whose self-reported compliance to their previous topical medication was optimal. Our results suggest that the IOP reduction found after switching to travoprost is not explainable by improved compliance due to the clinical study situation.