Objective: To compare efficacy and safety of bimato-prost (Lumigan) QD vs timolol/dorzolamide (Cosopt) BID. Methods: Randomized, double-masked, multicenter 3-month clinical trial. 177 patients with glaucoma or ocular ...Objective: To compare efficacy and safety of bimato-prost (Lumigan) QD vs timolol/dorzolamide (Cosopt) BID. Methods: Randomized, double-masked, multicenter 3-month clinical trial. 177 patients with glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOPs between 22 and 34 mmHg) after at least 2 weeks of timolol 0.5% monotherapy展开更多
Purpose: To review the effectiveness of bimatoprost in controlling IOP in patients who have failed on multiple medications. Methods: A retrospective chart review was conducted on 66 glaucoma patients who had previousl...Purpose: To review the effectiveness of bimatoprost in controlling IOP in patients who have failed on multiple medications. Methods: A retrospective chart review was conducted on 66 glaucoma patients who had previously failed on latanoprost and other medications due to non-responsiveness or allergy, and who展开更多
Purpose: To compare the effect of bimatoprost, latanoprost, travoprost and unoprostone on intraocular pressure and on ocular blood flow. Methods: A 3 month prospective randomized study with 92 patients with primary op...Purpose: To compare the effect of bimatoprost, latanoprost, travoprost and unoprostone on intraocular pressure and on ocular blood flow. Methods: A 3 month prospective randomized study with 92 patients with primary open angle glaucoma or ocular hypertension without previous treatment for glaucoma or intraocular surgery. Intraocular pressure (IOP) pulse volume (PV)展开更多
AIM： To establish the efficacy and safety of bimatoprost 0.03% monotherapy in glaucoma and ocular hypertension （OHT） patients with inadequate intraocular pressure （lOP） on current therapy. METHODS： Pre- and pos...AIM： To establish the efficacy and safety of bimatoprost 0.03% monotherapy in glaucoma and ocular hypertension （OHT） patients with inadequate intraocular pressure （lOP） on current therapy. METHODS： Pre- and post-switch lOPs were analyzed for 59 consecutive patients who were switched from current therapy to bimatoprost monotherapy between 2011-2015. Demographic information, diagnosis, and any adverse events were recorded. Change in lOP post-pre switch was analyzed using a 2-sided Student＇s paired t-test at the 5% significance level. RESULTS： There was a statistically significant mean reduction in lOP at the first follow up visit, which was maintained at subsequent follow up visits for patients regardless of diagnosis, or pre-switch treatment （P〈0.001）. Subgroup analysis also demonstrated a statistically significant mean reduction in lOP when looking at OHT patients only, as well as patients with any diagnosis switched from latanoprost monotherapy to bimatoprost monotherapy （P〈0.001）. CONCLUSION： This is the largest independent data set which supports switching glaucoma patients with poor response to current treatment onto bimatoprost monotherapy before considering other adjuvant medical or more invasive therapy.展开更多
Purpose: Intraocular Pressure (IOP) control is the main goal in glaucoma treatment However, despite satisfactory control, the occurrence of side effects reduces compliance. This study was designed to test if an ophtha...Purpose: Intraocular Pressure (IOP) control is the main goal in glaucoma treatment However, despite satisfactory control, the occurrence of side effects reduces compliance. This study was designed to test if an ophthalmic preparation of 50% diluted bi-matoprost (bimatoprost 0.015%) achieves good IOP展开更多
Purpose: Conjunctival hyperemia has been reported as a frequent side effect of bimatoprost, a prostamide with efficacious ocular hypotensive action. To investigate the possible inflammatory basis of the hyperemia, we ...Purpose: Conjunctival hyperemia has been reported as a frequent side effect of bimatoprost, a prostamide with efficacious ocular hypotensive action. To investigate the possible inflammatory basis of the hyperemia, we analysed, by means of light microscopy, the conjunctival specimens of patients who developed ocular hyperemia during bimatoprost therapy and who underwent cataract surgery. Methods: Patients were divided in two groups;展开更多
Purpose: To evaluate the IOP-lowering efficacy of bimatoprost and travoprost for the treatment of glaucoma and ocular hypertension. Methods: Randomized, double-masked, parallel-group clinical trial. After completing a...Purpose: To evaluate the IOP-lowering efficacy of bimatoprost and travoprost for the treatment of glaucoma and ocular hypertension. Methods: Randomized, double-masked, parallel-group clinical trial. After completing a washout from all glaucoma medications, patients (n =27) were randomized to bimatoprost or travoprost for 6 months. Visits were at baseline, week 1,展开更多
Purpose: To compare the intraocular pressure (IOP)-lowering efficacy of topically administered bimatoprost 0.03% with la-tanoprost 0.005% in patients with ocular hypertension (OHT) or glaucoma. Design: Multicenter, in...Purpose: To compare the intraocular pressure (IOP)-lowering efficacy of topically administered bimatoprost 0.03% with la-tanoprost 0.005% in patients with ocular hypertension (OHT) or glaucoma. Design: Multicenter, investigator-masked, 6-month randomized clinical trial. Methods: After washout of glaucoma medications, patients with OHT or glaucoma were randomly as-展开更多
Objective: To evaluate the safety and efficacy of bimatoprost 0.03% (Lumigan) monotherapy in patients with glaucoma or ocular hypertension previously treated with timolol 0.5% gel-forming solution (Timoptic-XE) and la...Objective: To evaluate the safety and efficacy of bimatoprost 0.03% (Lumigan) monotherapy in patients with glaucoma or ocular hypertension previously treated with timolol 0.5% gel-forming solution (Timoptic-XE) and latanoprost 0.005% (Xalatan) dual therapy. Methods: An open-label, multicenter e-valuation of 83 patients. Patients were assigned to dual therapy with latanoprost qPM and timolol gel-forming solu-展开更多
Objectives: To compare ocular surface changes induced via glaucoma treatment in patients using fixed combinations of bimatoprost 0.03%/timolol 0.50%, timolol 0.50% or bimatoprost 0.01% eye drops. Methods: This is a pr...Objectives: To compare ocular surface changes induced via glaucoma treatment in patients using fixed combinations of bimatoprost 0.03%/timolol 0.50%, timolol 0.50% or bimatoprost 0.01% eye drops. Methods: This is a prospective, one center, open-label clinical trial. It was performed on 60 glaucoma patients between 01-01-2012 and 12-31-2012. These patients were randomly divided in three subgroups: bimatoprost 0.03%/timolol 0.50% fixed combination, timolol 0.50% and bimatoprost 0.01%. The Ocular Surface Disease Index (O.S.D.I.) was evaluated in all the glaucomatous patients of the three subgroups at basal time and after 6 and 12 months. All the results were statistically evaluated by Student t-test and one-way ANOVA. The results were considered statistically significant if p < 0.05. Results: All of the patients ended the clinical trial. There was no statistical significant difference between patients treated with the bimatoprost 0.03%/timolol 0.50% fixed combination and timolol 0.50% eye drops alone (p = 0.845). Instead, there was a statistically significant difference between bimatoprost 0.01% and bimatoprost 0.03%/timolol 0.50% patients (p = 0.05) and between bimatoprost 0.01% and timolol 0.50% eye drops alone (p = 0.049). Conclusions: This is a clinical trial based not on the hypotonising effect of these drugs but on their tolerability. The drug which showed the best tolerability is bimatoprost 0.01%.展开更多
Purpose: To evaluate rates of hyperemia in patients treated with latanoprost, bimatoprost, or travoprost and to compare groups in IOP response and costs. Methods: This 3-month, retrospective, multicenter, non-randomiz...Purpose: To evaluate rates of hyperemia in patients treated with latanoprost, bimatoprost, or travoprost and to compare groups in IOP response and costs. Methods: This 3-month, retrospective, multicenter, non-randomized, medical chart review included patients from 10 U.S. sites, who either initiated or changed to latanoprost, bimatoprost, or travoprost for the treatment of primary open-angle glaucoma or ocular hypertension after January 1, 2001. Patients had follow-up data for at least 3 months fol-展开更多
Purpose: To evaluate the pressure lowering effects of bimato-prost once daily at bedtime in patients who failed previous la- tanoprost treatment. Methods: This was a prospective case series of patients who did not ach...Purpose: To evaluate the pressure lowering effects of bimato-prost once daily at bedtime in patients who failed previous la- tanoprost treatment. Methods: This was a prospective case series of patients who did not achieve intraocular pressure (IOP) reduction of 15% with latanoprost, recruited to receive展开更多
Purpose: To evaluate the efficacy and safety of bimatoprost 0.03 percent given every evening versus timolol maleate 0.5 per-cent/dorzolamide 2 percent fixed combination (TDFC) given twice daily in open-angle glaucoma ...Purpose: To evaluate the efficacy and safety of bimatoprost 0.03 percent given every evening versus timolol maleate 0.5 per-cent/dorzolamide 2 percent fixed combination (TDFC) given twice daily in open-angle glaucoma and ocular hypertensive patients. Design: A single-masked, two center, crossover comparison with two eight-week treatment periods following a four-week medicine free run-in period. Diurnal curve intraoc-展开更多
Purpose: This is a retrospective, comparative, head-to-head, not commissioned study about the efficacy of bimato-prost 0.03%, brimonidine 0.2%, brinzolamide 1%, dorzolamide 2%, and travoprost 0.004%/timolol 0.5%-fixed...Purpose: This is a retrospective, comparative, head-to-head, not commissioned study about the efficacy of bimato-prost 0.03%, brimonidine 0.2%, brinzolamide 1%, dorzolamide 2%, and travoprost 0.004%/timolol 0.5%-fixed combinations in patients affected by na?ve open-angle glaucoma and IOP > 25 mmHg. Patients and Methods: Files from 70 patients (35 M, 35 F, mean age 69.52 y, S.D. 11.56, range: 37-87y) in our Glaucoma Service were retrospectively analyzed as long as 12 months. Every subgroup, including 14 age- and sex-matched patients, was allocated to 1 of the 5 groups of the fixed combinations monotherapy. Data recorded after 3 months follow-up were statistically analyzed by descriptive and ANOVA statistics as percentage of IOP reduction from baseline. Results: All the fixed combinations were effective in lowering IOP. The mean percentage reduction was: brimonidine/timolol 43.57%, dorzolamide/timolol 37.67%, bimatoprost/timolol 35.60%, travoprost/timolol 33.25% and brinzolamide/timolol 23.0%. The brimonidine/timolol fixed combination showed to be statistically significant more effective only than brinzolamide/timolol fixed combination (p = 0.001). Setting the α error to 5%, the power of the study is 26%, phi: 0.842. Discussion: In all this cohort of patients the target IOP was successfully achieved. All the fixed combinations used in this study had a very good profile of efficacy. Brimonidine, dorzolamide, bimatoprost and travoprost/timolol fixed combinations statistically significantly reduced the percentage of IOP from baseline (p = 0.001) more than brinzolamide/timolol fixed combination.展开更多
The research was carried out to establish a new reverse phase-HPLC stability indicating method for quantifying Bimatoprost & Timolol in ophthalmic solution. The experiment of Bimatoprost & Timolol in ophthalmi...The research was carried out to establish a new reverse phase-HPLC stability indicating method for quantifying Bimatoprost & Timolol in ophthalmic solution. The experiment of Bimatoprost & Timolol in ophthalmic solution method development was determined on Waters HPLC instrument using a UV Detector. The separation was done by using L11, Zorbex SB phenyl (4.6 mm × 250 mm internal diameter) 5 μm analytical column, containing mobile phase of Phosphate buffer (0.02 M), methanol, and acetonitrile [50:30:20 % v/v]. The method was run at 1 ml·min<sup>-1</sup> at 210 nm for Bimatoprost and 295 nm for Timolol for detection. The drug was eluted at 10.81 min for Bimatoprost and 3.77 min for Timolol. After developing the method, it was assured for the intended use by validation, which was done according to ICH Q2B guidelines. The analytical parameters checked were Specificity/Selectivity, linearity, Range, accuracy, ruggedness, and robustness. It was observed that the response of the detector was linear in the range of 6 - 18 μg/ml with a correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability-indicating assay method was established by using the samples generated by the forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative, and photolytic degradation, and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the quantitative analysis of Bimatoprost 0.3% + Timolol 0.5% Ophthalmic Solution drugs for pharmaceutical use. Currently, there is no official method for Bimatoprost & Timolol combination products in USP or BP. Available research work related to single Bimatoprost or Timolol products was not suitable for testing Bimatoprost and Timolol combination drugs. Additionally, there is no stability-indicating method to test Bimatoprost & Timolol combination products which insist us to do research and develop a new reverse phase-HPLC indicating method which will be faster and more accurate.展开更多
文摘Objective: To compare efficacy and safety of bimato-prost (Lumigan) QD vs timolol/dorzolamide (Cosopt) BID. Methods: Randomized, double-masked, multicenter 3-month clinical trial. 177 patients with glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOPs between 22 and 34 mmHg) after at least 2 weeks of timolol 0.5% monotherapy
文摘Purpose: To review the effectiveness of bimatoprost in controlling IOP in patients who have failed on multiple medications. Methods: A retrospective chart review was conducted on 66 glaucoma patients who had previously failed on latanoprost and other medications due to non-responsiveness or allergy, and who
文摘Purpose: To compare the effect of bimatoprost, latanoprost, travoprost and unoprostone on intraocular pressure and on ocular blood flow. Methods: A 3 month prospective randomized study with 92 patients with primary open angle glaucoma or ocular hypertension without previous treatment for glaucoma or intraocular surgery. Intraocular pressure (IOP) pulse volume (PV)
文摘AIM： To establish the efficacy and safety of bimatoprost 0.03% monotherapy in glaucoma and ocular hypertension （OHT） patients with inadequate intraocular pressure （lOP） on current therapy. METHODS： Pre- and post-switch lOPs were analyzed for 59 consecutive patients who were switched from current therapy to bimatoprost monotherapy between 2011-2015. Demographic information, diagnosis, and any adverse events were recorded. Change in lOP post-pre switch was analyzed using a 2-sided Student＇s paired t-test at the 5% significance level. RESULTS： There was a statistically significant mean reduction in lOP at the first follow up visit, which was maintained at subsequent follow up visits for patients regardless of diagnosis, or pre-switch treatment （P〈0.001）. Subgroup analysis also demonstrated a statistically significant mean reduction in lOP when looking at OHT patients only, as well as patients with any diagnosis switched from latanoprost monotherapy to bimatoprost monotherapy （P〈0.001）. CONCLUSION： This is the largest independent data set which supports switching glaucoma patients with poor response to current treatment onto bimatoprost monotherapy before considering other adjuvant medical or more invasive therapy.
文摘Purpose: Intraocular Pressure (IOP) control is the main goal in glaucoma treatment However, despite satisfactory control, the occurrence of side effects reduces compliance. This study was designed to test if an ophthalmic preparation of 50% diluted bi-matoprost (bimatoprost 0.015%) achieves good IOP
文摘Purpose: Conjunctival hyperemia has been reported as a frequent side effect of bimatoprost, a prostamide with efficacious ocular hypotensive action. To investigate the possible inflammatory basis of the hyperemia, we analysed, by means of light microscopy, the conjunctival specimens of patients who developed ocular hyperemia during bimatoprost therapy and who underwent cataract surgery. Methods: Patients were divided in two groups;
文摘Purpose: To evaluate the IOP-lowering efficacy of bimatoprost and travoprost for the treatment of glaucoma and ocular hypertension. Methods: Randomized, double-masked, parallel-group clinical trial. After completing a washout from all glaucoma medications, patients (n =27) were randomized to bimatoprost or travoprost for 6 months. Visits were at baseline, week 1,
文摘Purpose: To compare the intraocular pressure (IOP)-lowering efficacy of topically administered bimatoprost 0.03% with la-tanoprost 0.005% in patients with ocular hypertension (OHT) or glaucoma. Design: Multicenter, investigator-masked, 6-month randomized clinical trial. Methods: After washout of glaucoma medications, patients with OHT or glaucoma were randomly as-
文摘Objective: To evaluate the safety and efficacy of bimatoprost 0.03% (Lumigan) monotherapy in patients with glaucoma or ocular hypertension previously treated with timolol 0.5% gel-forming solution (Timoptic-XE) and latanoprost 0.005% (Xalatan) dual therapy. Methods: An open-label, multicenter e-valuation of 83 patients. Patients were assigned to dual therapy with latanoprost qPM and timolol gel-forming solu-
文摘Objectives: To compare ocular surface changes induced via glaucoma treatment in patients using fixed combinations of bimatoprost 0.03%/timolol 0.50%, timolol 0.50% or bimatoprost 0.01% eye drops. Methods: This is a prospective, one center, open-label clinical trial. It was performed on 60 glaucoma patients between 01-01-2012 and 12-31-2012. These patients were randomly divided in three subgroups: bimatoprost 0.03%/timolol 0.50% fixed combination, timolol 0.50% and bimatoprost 0.01%. The Ocular Surface Disease Index (O.S.D.I.) was evaluated in all the glaucomatous patients of the three subgroups at basal time and after 6 and 12 months. All the results were statistically evaluated by Student t-test and one-way ANOVA. The results were considered statistically significant if p < 0.05. Results: All of the patients ended the clinical trial. There was no statistical significant difference between patients treated with the bimatoprost 0.03%/timolol 0.50% fixed combination and timolol 0.50% eye drops alone (p = 0.845). Instead, there was a statistically significant difference between bimatoprost 0.01% and bimatoprost 0.03%/timolol 0.50% patients (p = 0.05) and between bimatoprost 0.01% and timolol 0.50% eye drops alone (p = 0.049). Conclusions: This is a clinical trial based not on the hypotonising effect of these drugs but on their tolerability. The drug which showed the best tolerability is bimatoprost 0.01%.
文摘Purpose: To evaluate rates of hyperemia in patients treated with latanoprost, bimatoprost, or travoprost and to compare groups in IOP response and costs. Methods: This 3-month, retrospective, multicenter, non-randomized, medical chart review included patients from 10 U.S. sites, who either initiated or changed to latanoprost, bimatoprost, or travoprost for the treatment of primary open-angle glaucoma or ocular hypertension after January 1, 2001. Patients had follow-up data for at least 3 months fol-
文摘Purpose: To evaluate the pressure lowering effects of bimato-prost once daily at bedtime in patients who failed previous la- tanoprost treatment. Methods: This was a prospective case series of patients who did not achieve intraocular pressure (IOP) reduction of 15% with latanoprost, recruited to receive
文摘Purpose: To evaluate the efficacy and safety of bimatoprost 0.03 percent given every evening versus timolol maleate 0.5 per-cent/dorzolamide 2 percent fixed combination (TDFC) given twice daily in open-angle glaucoma and ocular hypertensive patients. Design: A single-masked, two center, crossover comparison with two eight-week treatment periods following a four-week medicine free run-in period. Diurnal curve intraoc-
文摘Purpose: This is a retrospective, comparative, head-to-head, not commissioned study about the efficacy of bimato-prost 0.03%, brimonidine 0.2%, brinzolamide 1%, dorzolamide 2%, and travoprost 0.004%/timolol 0.5%-fixed combinations in patients affected by na?ve open-angle glaucoma and IOP > 25 mmHg. Patients and Methods: Files from 70 patients (35 M, 35 F, mean age 69.52 y, S.D. 11.56, range: 37-87y) in our Glaucoma Service were retrospectively analyzed as long as 12 months. Every subgroup, including 14 age- and sex-matched patients, was allocated to 1 of the 5 groups of the fixed combinations monotherapy. Data recorded after 3 months follow-up were statistically analyzed by descriptive and ANOVA statistics as percentage of IOP reduction from baseline. Results: All the fixed combinations were effective in lowering IOP. The mean percentage reduction was: brimonidine/timolol 43.57%, dorzolamide/timolol 37.67%, bimatoprost/timolol 35.60%, travoprost/timolol 33.25% and brinzolamide/timolol 23.0%. The brimonidine/timolol fixed combination showed to be statistically significant more effective only than brinzolamide/timolol fixed combination (p = 0.001). Setting the α error to 5%, the power of the study is 26%, phi: 0.842. Discussion: In all this cohort of patients the target IOP was successfully achieved. All the fixed combinations used in this study had a very good profile of efficacy. Brimonidine, dorzolamide, bimatoprost and travoprost/timolol fixed combinations statistically significantly reduced the percentage of IOP from baseline (p = 0.001) more than brinzolamide/timolol fixed combination.
文摘The research was carried out to establish a new reverse phase-HPLC stability indicating method for quantifying Bimatoprost & Timolol in ophthalmic solution. The experiment of Bimatoprost & Timolol in ophthalmic solution method development was determined on Waters HPLC instrument using a UV Detector. The separation was done by using L11, Zorbex SB phenyl (4.6 mm × 250 mm internal diameter) 5 μm analytical column, containing mobile phase of Phosphate buffer (0.02 M), methanol, and acetonitrile [50:30:20 % v/v]. The method was run at 1 ml·min<sup>-1</sup> at 210 nm for Bimatoprost and 295 nm for Timolol for detection. The drug was eluted at 10.81 min for Bimatoprost and 3.77 min for Timolol. After developing the method, it was assured for the intended use by validation, which was done according to ICH Q2B guidelines. The analytical parameters checked were Specificity/Selectivity, linearity, Range, accuracy, ruggedness, and robustness. It was observed that the response of the detector was linear in the range of 6 - 18 μg/ml with a correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability-indicating assay method was established by using the samples generated by the forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative, and photolytic degradation, and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the quantitative analysis of Bimatoprost 0.3% + Timolol 0.5% Ophthalmic Solution drugs for pharmaceutical use. Currently, there is no official method for Bimatoprost & Timolol combination products in USP or BP. Available research work related to single Bimatoprost or Timolol products was not suitable for testing Bimatoprost and Timolol combination drugs. Additionally, there is no stability-indicating method to test Bimatoprost & Timolol combination products which insist us to do research and develop a new reverse phase-HPLC indicating method which will be faster and more accurate.
