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Scott M Whitcup - One of the best experts on this subject based on the ideXlab platform.
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Bimatoprost sustained release implants for glaucoma therapy 6 month results from a phase i ii clinical trial
American Journal of Ophthalmology, 2017Co-Authors: Richard A. Lewis, Douglas G. Day, Marina Bejanian, Randy E Craven, Susan S Lee, Thomas Walters, William C. Christie, Margot L. Goodkin, Jane Zhang, Scott M WhitcupAbstract:Purpose To evaluate the safety and intraocular pressure (IOP)-lowering effect of a biodegradable Bimatoprost sustained-release implant (Bimatoprost SR). Design Phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. Methods At baseline following washout, open-angle glaucoma patients (n = 75) were administered Bimatoprost SR (6 μg, 10 μg, 15 μg, or 20 μg) intracamerally in the study eye; the fellow eye began topical Bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or a single repeat treatment with implant was allowed. The primary endpoint was IOP change from baseline. The main safety measure was adverse events. Results through month 6 are reported. Results Bimatoprost SR provided rapid, sustained IOP lowering. Overall mean IOP reduction from baseline through week 16 in study eyes was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6-μg, 10-μg, 15-μg, and 20-μg dose strengths of implant, respectively, vs 8.4 mm Hg in topical Bimatoprost-treated pooled fellow eyes (data censored at rescue/retreatment). Rescue/retreatment was not required in 91% and 71% of study eyes up to week 16 and month 6, respectively. Adverse events in study eyes usually occurred within 2 days after the injection procedure and were transient. Conjunctival hyperemia with onset later than 2 days after the injection procedure was more common with topical Bimatoprost than Bimatoprost SR (17.3% vs 6.7% of eyes). Conclusions Bimatoprost SR demonstrated favorable efficacy and safety through 6 months. All dose strengths were comparable to topical Bimatoprost in overall IOP reduction through week 16. A single administration controlled IOP in the majority of patients for up to 6 months.
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eyelash growth in subjects treated with Bimatoprost a multicenter randomized double masked vehicle controlled parallel group study
Journal of The American Academy of Dermatology, 2012Co-Authors: Stacy Smith, Emily Weng, Frederick C Beddingfield, Scott M Whitcup, Steven Fagien, Fred Ledon, Christine SomogyiAbstract:Background Bimatoprost 0.03% is associated with increased growth and prominence of eyelashes. Objective We sought to compare the safety and efficacy of once-daily Bimatoprost 0.03% versus vehicle in increasing eyelash length, thickness, and darkness after topical administration to upper eyelid margins. Methods In this 5-month study, subjects were randomized to receive once-daily Bimatoprost 0.03% (n = 137) or vehicle (n = 141). The primary end point was eyelash prominence assessed by the investigator global eyelash assessment scale. Secondary efficacy measures included eyelash length, thickness, and darkness measured by digital image analysis and patient-reported outcomes. Safety data included adverse event monitoring and ophthalmic examinations. Results A higher percentage of subjects treated with Bimatoprost 0.03% (78.1%) versus vehicle (18.4%) demonstrated at least a 1-grade increase in global eyelash assessment score at week 16 ( P P P = .03). Limitations Short-term duration of the trial was a limitation; black subjects were not enrolled secondary to technical requirements of digital image analysis. Conclusion Bimatoprost 0.03% was found to be effective at enhancing eyelashes in adults with a very good safety profile.
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a randomized controlled comparison of macroscopic conjunctival hyperemia in patients treated with Bimatoprost 0 01 or vehicle who were previously controlled on latanoprost
Clinical Ophthalmology, 2010Co-Authors: Randy E Craven, Rhett M Schiffman, Ching Chi Liu, Amy L Batoosingh, Scott M WhitcupAbstract:Purpose To evaluate conjunctival hyperemia associated with Bimatoprost 0.01% treatment in patients who replace latanoprost 0.005% with Bimatoprost 0.01%.
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two year double masked comparison of Bimatoprost with timolol in patients with glaucoma or ocular hypertension
Survey of Ophthalmology, 2004Co-Authors: John S Cohen, Paula Bernstein, Ronald L Gross, Janet K Cheetham, Amanda M Vandenburgh, Scott M WhitcupAbstract:The object of this study was to compare the long term efficacy and safety of Bimatoprost with timolol in patients with glaucoma or ocular hypertension. In a 12-month extension of two identically designed 1-year, multicenter, randomized, double-masked clinical trials, patients were treated topically with Bimatoprost 0.03% QD (n=167), Bimatoprost 0.03% BID (n=131), or timolol 0.5% BID (n=81). Main outcome measures were IOP at 8 am and 10 am and safety parameters. Bimatoprost QD provided significantly greater mean reduction from baseline IOP than did timolol at both measurements at each study visit (P< or =.001). At 10 am (peak timolol effect) at month 24, the mean reduction from baseline IOP was 7.8 mm Hg with Bimatoprost QD and 4.6 mm Hg with timolol (P<.001). Patients treated with Bimatoprost QD also sustained significantly lower mean IOP than timolol-treated patients at every follow-up visit throughout the 2-year study period (P< or =.006). At 10 am at month 24, a significantly greater proportion of Bimatoprost QD than timolol patients achieved target pressures of < or =13-18 mm Hg (P< or =.010). Bimatoprost sustained an excellent safety profile during the second year of treatment. Most adverse events were mild, and there were no reports of increased iris pigmentation, uveitis, or CME. The incidence of hyperemia was significantly higher with Bimatoprost QD (13.8%) than with timolol (2.5%) (P=.006). Mean reduction from baseline IOP with Bimatoprost BID was not significantly different from that with timolol at month 24 at 10 am (P=.474). We conclude that Bimatoprost QD provides superior IOP lowering to timolol, and is safe and well tolerated over 24 months of treatment.
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a 3 month randomized controlled trial of Bimatoprost lumigan versus combined timolol and dorzolamide cosopt in patients with glaucoma or ocular hypertension
Ophthalmology, 2003Co-Authors: Anne L Coleman, Fabian Lerner, Paula Bernstein, Scott M WhitcupAbstract:Abstract Purpose To compare the efficacy and safety of topical Bimatoprost (LUMIGAN; Allergan, Inc., Irvine, CA) once daily with that of topical combined timolol and dorzolamide (Cosopt; Merck & Co, Inc., Whitehouse Station, NJ) twice daily. Design Prospective, randomized, double-masked, multicenter clinical trial. Participants One hundred seventy-seven patients with a diagnosis of glaucoma or ocular hypertension and inadequate control of intraocular pressure (IOP) after at least 2 weeks of topical timolol maleate 0.5% monotherapy. Methods Patients were randomized to receive Bimatoprost 0.03% once daily (n = 90) or combined timolol 0.5% and dorzolamide 2% twice daily (n = 87) over a 3-month period. Main outcome measures Intraocular pressure, the primary end point, was measured at 8 am and 10 am at baseline, week 1, and months 1, 2, and 3, and also at 4 pm and 8 pm at baseline and month 3. Results Bimatoprost provided significantly greater IOP lowering compared with combined timolol and dorzolamide. At the 8 am measurements, Bimatoprost lowered mean IOP 6.8 mmHg to 7.6 mmHg from baseline, whereas combined timolol and dorzolamide lowered mean IOP 4.4 to 5.0 mmHg from baseline ( P P ≤0.008). Taste perversion, ocular burning, and stinging with instillation were more common with combined timolol and dorzolamide, whereas conjunctival hyperemia was more common with Bimatoprost. Conclusions In individuals with glaucoma or ocular hypertension, uncontrolled on a topical β-blocker alone, Bimatoprost lowered IOP more consistently than did combined timolol and dorzolamide.
Marina Bejanian - One of the best experts on this subject based on the ideXlab platform.
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24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients
Drugs, 2020Co-Authors: E. Randy Craven, Douglas G. Day, Michael R Robinson, Thomas Walters, William C. Christie, Richard A. Lewis, Margot L. Goodkin, Michelle Chen, Veronica Wangsadipura, Marina BejanianAbstract:Objective The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable Bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical Bimatoprost 0.03% in patients with open-angle glaucoma (OAG). Methods This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG ( N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical Bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs). Results At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. Conclusions Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical Bimatoprost. Targeted and sustained delivery of Bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364
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24 month phase i ii clinical trial of Bimatoprost sustained release implant Bimatoprost sr in glaucoma patients
Drugs, 2020Co-Authors: Randy E Craven, Douglas G. Day, Thomas R Walters, Michael R Robinson, William C. Christie, Richard A. Lewis, Margot L. Goodkin, Veronica Wangsadipura, Michelle Y Chen, Marina BejanianAbstract:The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable Bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical Bimatoprost 0.03% in patients with open-angle glaucoma (OAG). This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical Bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs). At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical Bimatoprost. Targeted and sustained delivery of Bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364
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intracameral sustained release Bimatoprost implant delivers Bimatoprost to target tissues with reduced drug exposure to off target tissues
Journal of Ocular Pharmacology and Therapeutics, 2019Co-Authors: Jennifer Seal, Marina Bejanian, Michael R Robinson, James A Burke, Michael Coote, Mayssa AttarAbstract:Abstract Purpose: To explore the ocular distribution of Bimatoprost after intracameral administration of a biodegradable sustained-release Bimatoprost implant (Bimatoprost SR) versus repeated topic...
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Bimatoprost sustained release implants for glaucoma therapy 6 month results from a phase i ii clinical trial
American Journal of Ophthalmology, 2017Co-Authors: Richard A. Lewis, Douglas G. Day, Marina Bejanian, Randy E Craven, Susan S Lee, Thomas Walters, William C. Christie, Margot L. Goodkin, Jane Zhang, Scott M WhitcupAbstract:Purpose To evaluate the safety and intraocular pressure (IOP)-lowering effect of a biodegradable Bimatoprost sustained-release implant (Bimatoprost SR). Design Phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. Methods At baseline following washout, open-angle glaucoma patients (n = 75) were administered Bimatoprost SR (6 μg, 10 μg, 15 μg, or 20 μg) intracamerally in the study eye; the fellow eye began topical Bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or a single repeat treatment with implant was allowed. The primary endpoint was IOP change from baseline. The main safety measure was adverse events. Results through month 6 are reported. Results Bimatoprost SR provided rapid, sustained IOP lowering. Overall mean IOP reduction from baseline through week 16 in study eyes was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6-μg, 10-μg, 15-μg, and 20-μg dose strengths of implant, respectively, vs 8.4 mm Hg in topical Bimatoprost-treated pooled fellow eyes (data censored at rescue/retreatment). Rescue/retreatment was not required in 91% and 71% of study eyes up to week 16 and month 6, respectively. Adverse events in study eyes usually occurred within 2 days after the injection procedure and were transient. Conjunctival hyperemia with onset later than 2 days after the injection procedure was more common with topical Bimatoprost than Bimatoprost SR (17.3% vs 6.7% of eyes). Conclusions Bimatoprost SR demonstrated favorable efficacy and safety through 6 months. All dose strengths were comparable to topical Bimatoprost in overall IOP reduction through week 16. A single administration controlled IOP in the majority of patients for up to 6 months.
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Bimatoprost 0 03 timolol 0 5 preservative free ophthalmic solution versus Bimatoprost 0 03 timolol 0 5 ophthalmic solution ganfort for glaucoma or ocular hypertension a 12 week randomised controlled trial
British Journal of Ophthalmology, 2014Co-Authors: Ivan Goldberg, Rhett M Schiffman, Charlie Liu, Rafael Gil Pina, Aitor Lanzagortaaresti, Marina BejanianAbstract:Aim To compare the efficacy and safety of single-dose Bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with Bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. Methods In this multicentre, randomised, parallel-group study, patients were randomised to Bimatoprost/timolol PF or Bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. Results 561 patients were randomised (278 to Bimatoprost/timolol PF; 283 to Bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p Conclusions Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with Bimatoprost/timolol, with no significant differences in safety and tolerability. Trial registration number NCT01177098.
Rhett M Schiffman - One of the best experts on this subject based on the ideXlab platform.
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Bimatoprost 0 03 timolol 0 5 preservative free ophthalmic solution versus Bimatoprost 0 03 timolol 0 5 ophthalmic solution ganfort for glaucoma or ocular hypertension a 12 week randomised controlled trial
British Journal of Ophthalmology, 2014Co-Authors: Ivan Goldberg, Rhett M Schiffman, Charlie Liu, Rafael Gil Pina, Aitor Lanzagortaaresti, Marina BejanianAbstract:Aim To compare the efficacy and safety of single-dose Bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with Bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. Methods In this multicentre, randomised, parallel-group study, patients were randomised to Bimatoprost/timolol PF or Bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. Results 561 patients were randomised (278 to Bimatoprost/timolol PF; 283 to Bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p Conclusions Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with Bimatoprost/timolol, with no significant differences in safety and tolerability. Trial registration number NCT01177098.
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Bimatoprost 0 03 preservative free ophthalmic solution versus Bimatoprost 0 03 ophthalmic solution lumigan for glaucoma or ocular hypertension a 12 week randomised double masked trial
British Journal of Ophthalmology, 2013Co-Authors: Douglas G. Day, Rhett M Schiffman, Thomas R Walters, Gail F. Schwartz, Thomas K Mundorf, Charlie Liu, Marina BejanianAbstract:Background/Aim To evaluate efficacy and safety of Bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus Bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to Bimatoprost PF or Bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (Bimatoprost PF, n=302 and Bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was Conclusions Bimatoprost PF is non-inferior and equivalent to Bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to Bimatoprost.
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a randomized controlled comparison of macroscopic conjunctival hyperemia in patients treated with Bimatoprost 0 01 or vehicle who were previously controlled on latanoprost
Clinical Ophthalmology, 2010Co-Authors: Randy E Craven, Rhett M Schiffman, Ching Chi Liu, Amy L Batoosingh, Scott M WhitcupAbstract:Purpose To evaluate conjunctival hyperemia associated with Bimatoprost 0.01% treatment in patients who replace latanoprost 0.005% with Bimatoprost 0.01%.
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twelve month randomized controlled trial of Bimatoprost 0 01 0 0125 and 0 03 in patients with glaucoma or ocular hypertension
American Journal of Ophthalmology, 2010Co-Authors: Jay L Katz, John S Cohen, Amy L Batoosingh, Carlos Felix, Vincent Shu, Rhett M SchiffmanAbstract:Purpose To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of ophthalmic formulations of Bimatoprost 0.01% and 0.0125% compared with Bimatoprost 0.03%. Design Prospective, randomized, double-masked, multicenter clinical trial. Methods Patients with glaucoma or ocular hypertension were randomized to receive once-daily Bimatoprost 0.01% (n = 186), Bimatoprost 0.0125% (n = 188), or Bimatoprost 0.03% (n = 187) for 12 months. The primary efficacy measure was IOP. Safety measures included adverse events and an objective assessment of conjunctival hyperemia. Results Baseline mean IOPs were similar among treatment groups. Differences in mean IOP between the Bimatoprost 0.01% or 0.0125% groups and the Bimatoprost 0.03% group were less than 0.9 mm Hg throughout follow-up. Bimatoprost 0.01%, but not Bimatoprost 0.0125%, was equivalent in efficacy to Bimatoprost 0.03% based on predetermined criteria (limits of the 95% confidence interval of the between-group difference in mean IOP within ± 1.5 mm Hg at all time points and within ± 1 mm Hg at most time points). The overall incidence of treatment-related adverse events was reduced significantly in the Bimatoprost 0.01% and Bimatoprost 0.0125% groups compared with the Bimatoprost 0.03% group ( P ≤ .034). The percentage of patients with a moderate to severe increase from the baseline macroscopic hyperemia score was: Bimatoprost 0.01%, 3.2%; Bimatoprost 0.0125%, 9.0%; Bimatoprost 0.03%, 9.1% ( P = .019 for Bimatoprost 0.01% vs 0.03%). Conclusions Bimatoprost 0.01% was equivalent to Bimatoprost 0.03% in lowering IOP throughout 12 months of treatment and demonstrated improved tolerability, including less frequent and severe conjunctival hyperemia. Bimatoprost 0.01% demonstrated a better benefit-to-risk ratio than Bimatoprost 0.0125%.
Amanda M Vandenburgh - One of the best experts on this subject based on the ideXlab platform.
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Bimatoprost 0 03 for the treatment of eyebrow hypotrichosis
Dermatologic Surgery, 2016Co-Authors: Jean Carruthers, Amanda M Vandenburgh, Kenneth Beer, Alastair Carruthers, William P Coleman, Zoe Diana Draelos, Derek K Jones, Mitchel P Goldman, Michael L Pucci, Emily WengAbstract:Eyebrow loss may have substantial negative functional and social consequences. Evaluate the safety and efficacy of Bimatoprost 0.03% in subjects with eyebrow hypotrichosis. This multicenter, double-masked study randomized adult females or males with eyebrow hypotrichosis to receive Bimatoprost 0.03% twice (BID) or once daily (QD) or vehicle BID for 7 months. Primary endpoint was overall eyebrow fullness at Month 7. Secondary endpoints included eyebrow fullness (mm2), darkness (intensity units), and subject satisfaction with treatment. Safety was also assessed. At Month 7, the proportion of subjects with improvement was significantly higher in Bimatoprost groups versus vehicle (both, p < .001). Improvements occurred in both Bimatoprost groups versus vehicle after Month 1 and continued through follow-up; eyebrow fullness and darkness improved as early as Months 2 and 1, respectively (both, p < .001). Greater satisfaction was reported with Bimatoprost versus vehicle at Month 2 and all subsequent time points. Overall, 38.1%, 42.4%, and 35.5% of subjects in the Bimatoprost BID, QD, and vehicle groups, respectively, experienced ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs were similar across groups. No skin or iris hyperpigmentation or conjunctival hyperemia occurred. Bimatoprost 0.03% BID and QD is safe, well tolerated, and effective for eyebrow hypotrichosis. This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0 (CC BY-NC-ND), which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially.
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two year double masked comparison of Bimatoprost with timolol in patients with glaucoma or ocular hypertension
Survey of Ophthalmology, 2004Co-Authors: John S Cohen, Paula Bernstein, Ronald L Gross, Janet K Cheetham, Amanda M Vandenburgh, Scott M WhitcupAbstract:The object of this study was to compare the long term efficacy and safety of Bimatoprost with timolol in patients with glaucoma or ocular hypertension. In a 12-month extension of two identically designed 1-year, multicenter, randomized, double-masked clinical trials, patients were treated topically with Bimatoprost 0.03% QD (n=167), Bimatoprost 0.03% BID (n=131), or timolol 0.5% BID (n=81). Main outcome measures were IOP at 8 am and 10 am and safety parameters. Bimatoprost QD provided significantly greater mean reduction from baseline IOP than did timolol at both measurements at each study visit (P< or =.001). At 10 am (peak timolol effect) at month 24, the mean reduction from baseline IOP was 7.8 mm Hg with Bimatoprost QD and 4.6 mm Hg with timolol (P<.001). Patients treated with Bimatoprost QD also sustained significantly lower mean IOP than timolol-treated patients at every follow-up visit throughout the 2-year study period (P< or =.006). At 10 am at month 24, a significantly greater proportion of Bimatoprost QD than timolol patients achieved target pressures of < or =13-18 mm Hg (P< or =.010). Bimatoprost sustained an excellent safety profile during the second year of treatment. Most adverse events were mild, and there were no reports of increased iris pigmentation, uveitis, or CME. The incidence of hyperemia was significantly higher with Bimatoprost QD (13.8%) than with timolol (2.5%) (P=.006). Mean reduction from baseline IOP with Bimatoprost BID was not significantly different from that with timolol at month 24 at 10 am (P=.474). We conclude that Bimatoprost QD provides superior IOP lowering to timolol, and is safe and well tolerated over 24 months of treatment.
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24 hour iop control with once daily Bimatoprost timolol gel forming solution or latanoprost a 1 month randomized comparative clinical trial
Survey of Ophthalmology, 2004Co-Authors: Tom R Walters, Harvey Dubiner, Susan P Carpenter, Bashir Khan, Amanda M VandenburghAbstract:Abstract Purpose To compare the efficacy and safety of once-daily (QD) Bimatoprost, latanoprost, and timolol gel-forming solution in providing 24-hour intraocular pressure (IOP) control. Design This was a randomized, multicenter, investigator-masked, prospective, parallel-group, clinical trial. Participants Patients with open-angle glaucoma or ocular hypertension. Intervention After washout of any previous ocular hypotensive medications, patients were randomly assigned to treatment with Bimatoprost 0.03% ophthalmic solution QD (n = 38) or latanoprost 0.005% ophthalmic solution QD (n = 38) between 7 and 9 pm , or timolol maleate 0.5% gel-forming ophthalmic solution QD (n = 39) between 7 and 9 am for 1 month. Main outcome measures The primary outcome measure, circadian IOP, was measured at eight time points over the course of 24 hours beginning at 8 am on day 28 and with the last measurement at 8 am on day 29. IOP was also measured at 8 am and 10 am at baseline and at 8 am on day 14. Safety measures included adverse events, biomicroscopy, visual acuity, heart rate, and blood pressure. Results At 10 am (peak drug effect) on day 28, the mean IOP reduction from baseline was significantly greater with Bimatoprost (9.3 mm Hg, 40.3%) than with timolol gel (7.1 mm Hg, 31.1%; P = .024, Wilcoxon rank sum test) or latanoprost (7.4 mm Hg, 33.3%). In the overall analysis of IOP measured over the course of 24 hours, mean IOP was significantly lower with Bimatoprost or latanoprost than with timolol gel ( P P = .003). In the area-under-the-curve analysis, Bimatoprost and latanoprost were superior to timolol gel ( P ≤.018) but comparable to each other ( P ≥.223). All treatment regimens were well tolerated, with few discontinuations due to adverse events. There were no significant effects on systemic safety parameters. Conclusion Once-daily Bimatoprost or latanoprost provided significantly better 24-hour IOP control than timolol gel in patients with glaucoma or ocular hypertension. Some measurements suggested a trend for greater efficacy of Bimatoprost over latanoprost. All three treatments were well tolerated.
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a randomised double masked multicentre clinical trial comparing Bimatoprost and timolol for the treatment of glaucoma and ocular hypertension
British Journal of Ophthalmology, 2003Co-Authors: Scott M Whitcup, Louis B Cantor, Amanda M Vandenburgh, Kuankuan ChenAbstract:Aim: To evaluate the safety and efficacy of Bimatoprost 0.03% once daily or twice daily compared with timolol 0.5% twice daily in patients with glaucoma or ocular hypertension. Methods: Multicentre, double masked, randomised, parallel group, 3 month trial comparing Bimatoprost once daily (n=240), Bimatoprost twice daily (n=240), and timolol twice daily (n=122). The primary efficacy end point was diurnal intraocular pressure (IOP) (8 am, 10 am, 4 pm). Safety measures included adverse events, ocular parameters, and systemic variables. Results: Bimatoprost once daily provided significantly lower mean IOP than timolol twice daily at all times and follow up visits (p<0.001). At month 3, mean IOP reductions from baseline at 10 am (peak timolol effect) were Bimatoprost once daily, 8.0 mm Hg (32.4%); Bimatoprost twice daily, 6.3 mm Hg (25.2%); timolol, 5.5 mm Hg (22.7%). Bimatoprost twice daily was also more effective than timolol, but was not as effective as Bimatoprost once daily. A higher percentage of patients achieved low target pressures with Bimatoprost once daily than with timolol. The most frequent side effects with Bimatoprost were eyelash growth and mild conjunctival hyperaemia. Systemic safety parameters were not affected by Bimatoprost. Conclusions: Bimatoprost 0.03% once daily demonstrated superior efficacy compared with timolol 0.5% twice daily in patients with elevated IOP. Bimatoprost once daily was more effective than twice daily dosing.
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one year randomized study comparing Bimatoprost and timolol in glaucoma and ocular hypertension
Archives of Ophthalmology, 2002Co-Authors: Eve J Higginbotham, Ivan Goldberg, Joel S Schuman, Ronald L Gross, Amanda M Vandenburgh, Kuankuan Chen, Scott M WhitcupAbstract:Objective To compare Bimatoprost with timolol maleate in patients with glaucoma or ocular hypertension. Methods In 2 identical, multicenter, randomized, double-masked, 1-year clinical trials, patients were treated with 0.03% Bimatoprost once daily (QD) (n = 474), 0.03% Bimatoprost twice daily (BID) (n = 483), or 0.5% timolol maleate BID (n = 241). Main Outcome Measures Diurnal intraocular pressure (IOP) at 8 AM, 10 AM, and 4 PM and safety variables (IOP was also measured at 8 PM at selected sites). Results Bimatoprost QD provided significantly lower mean IOP than timolol at every time of the day at each study visit ( P P P P Conclusions Bimatoprost QD provides sustained IOP lowering superior to timolol or Bimatoprost BID and achieves low target IOPs in significantly more patients.
Frederick C Beddingfield - One of the best experts on this subject based on the ideXlab platform.
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long term safety and efficacy of Bimatoprost solution 0 03 application to the eyelid margin for the treatment of idiopathic and chemotherapy induced eyelash hypotrichosis a randomized controlled trial
British Journal of Dermatology, 2015Co-Authors: D A Glaser, Emily Weng, Parwez Hossain, W Perkins, T Griffiths, G Ahluwalia, Frederick C BeddingfieldAbstract:BACKGROUND: Bimatoprost ophthalmic solution 0.03% is approved in several countries for treating eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis. OBJECTIVE: Evaluate long-term safety and efficacy of Bimatoprost among subjects with idiopathic or chemotherapy-induced hypotrichosis. METHODS: This multicentre, double-masked, randomised, parallel-group study included two 6-month treatment periods. Subjects with idiopathic hypotrichosis were randomised to 3 treatment groups: 1) treatment period 1 (TP1) and TP2: Bimatoprost; 2) TP1: Bimatoprost; TP2: vehicle; and 3) TP1: vehicle; TP2: Bimatoprost. Subjects with chemotherapy-induced hypotrichosis were randomised to 2 treatment groups: 1) TP1: Bimatoprost or vehicle; and 2) TP2: Bimatoprost. The primary endpoint was a composite of at least a 1-grade improvement in investigator-assessed Global Eyelash Assessment (GEA), and at least a 3-point improvement in subject-reported Eyelash Satisfaction Questionnaire (ESQ) Domain 2 (self-perceived confidence, attractiveness, and professionalism) at month 4. Secondary measures included digitally assessed eyelash characteristics (ie, eyelash length, fullness, and darkness). RESULTS: The study randomised 368 subjects. The primary efficacy endpoint was met in both populations (responder rates: idiopathic: 40.2% Bimatoprost vs 6.8% vehicle; post-chemotherapy: 37.5% Bimatoprost vs 18.2% vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (post-chemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4 to 6 months following treatment cessation in subjects with idiopathic hypotrichosis. No drug-related serious adverse events were reported. CONCLUSIONS: Daily treatment with Bimatoprost ophthalmic solution 0.03% for 1 year was effective and well tolerated in subjects with idiopathic and chemotherapy-induced hypotrichosis.
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patient reported outcomes of Bimatoprost for eyelash growthresults from a randomized double masked vehicle controlled parallel group study
Aesthetic Surgery Journal, 2013Co-Authors: Steven Fagien, Emily Weng, Jean Carruthers, John G Walt, Sue Ellen Cox, David Wirta, Frederick C BeddingfieldAbstract:Background: Hypotrichosis of the eyelashes may negatively influence an individual's self-perception and appearance. Assessing the impact of treatment from a patient's perspective may be particularly relevant in trials of aesthetic agents. Once-daily dermal (topically applied) administration of Bimatoprost ophthalmic solution 0.03% has been associated with increased eyelash prominence (ie, length, thickness, darkness). Objectives: The authors assess patient-reported outcomes (PRO) after treatment with Bimatoprost for hypotrichosis of the eyelashes. Methods: In this multicenter, double-masked, randomized, vehicle-controlled, parallel clinical trial, 4 PRO questionnaires were distributed to 278 patients (Bimatoprost [n = 137] and vehicle [n = 141]). The primary PRO questionnaire was the 23-item Eyelash Satisfaction Questionnaire (ESQ), which measured satisfaction in 3 domains: length, fullness, and overall satisfaction (LFOS); confidence, attractiveness, and professionalism (CAP); and impact on daily routine (DR). Results: By week 16, the Bimatoprost group reported significantly greater improvements from baseline on all ESQ items ( P ≤ .0433). These improvements were sustained through the 4-week posttreatment study visit. Patient satisfaction was significantly greater in the Bimatoprost group than in the vehicle group for all 3 domains: LFOS (weeks 8-20; P ≤ .0052), CAP (weeks 12-20; P < .0001), and DR (weeks 16 and 20; P ≤ .01). Conclusions: The Bimatoprost group reported significantly greater levels of positive patient outcomes and satisfaction than the vehicle group across all 23 questions and all 3 domains of the primary PRO questionnaire. These results support the effectiveness, as measured by objective measures and PRO, of once-daily Bimatoprost ophthalmic solution 0.03% at producing more prominent eyelashes in adults. Level of Evidence: 2 ![Graphic][1] [1]: /embed/inline-graphic-1.gif
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patient reported outcomes of Bimatoprost for eyelash growth results from a randomized double masked vehicle controlled parallel group study
Aesthetic Surgery Journal, 2013Co-Authors: Steven Fagien, Emily Weng, Jean Carruthers, John G Walt, Sue Ellen Cox, David Wirta, Frederick C BeddingfieldAbstract:Background: Hypotrichosis of the eyelashes may negatively influence an individual's self-perception and appearance. Assessing the impact of treatment from a patient's perspective may be particularly relevant in trials of aesthetic agents. Once-daily dermal (topically applied) administration of Bimatoprost ophthalmic solution 0.03% has been associated with increased eyelash prominence (ie, length, thickness, darkness). Objectives: The authors assess patient-reported outcomes (PRO) after treatment with Bimatoprost for hypotrichosis of the eyelashes. Methods: In this multicenter, double-masked, randomized, vehicle-controlled, parallel clinical trial, 4 PRO questionnaires were distributed to 278 patients (Bimatoprost [n = 137] and vehicle [n = 141]). The primary PRO questionnaire was the 23-item Eyelash Satisfaction Questionnaire (ESQ), which measured satisfaction in 3 domains: length, fullness, and overall satisfaction (LFOS); confidence, attractiveness, and professionalism (CAP); and impact on daily routine (DR). Results: By week 16, the Bimatoprost group reported significantly greater improvements from baseline on all ESQ items ( P ≤ .0433). These improvements were sustained through the 4-week posttreatment study visit. Patient satisfaction was significantly greater in the Bimatoprost group than in the vehicle group for all 3 domains: LFOS (weeks 8-20; P ≤ .0052), CAP (weeks 12-20; P < .0001), and DR (weeks 16 and 20; P ≤ .01). Conclusions: The Bimatoprost group reported significantly greater levels of positive patient outcomes and satisfaction than the vehicle group across all 23 questions and all 3 domains of the primary PRO questionnaire. These results support the effectiveness, as measured by objective measures and PRO, of once-daily Bimatoprost ophthalmic solution 0.03% at producing more prominent eyelashes in adults. Level of Evidence: 2 ![Graphic][1] [1]: /embed/inline-graphic-1.gif
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eyelash growth in subjects treated with Bimatoprost a multicenter randomized double masked vehicle controlled parallel group study
Journal of The American Academy of Dermatology, 2012Co-Authors: Stacy Smith, Emily Weng, Frederick C Beddingfield, Scott M Whitcup, Steven Fagien, Fred Ledon, Christine SomogyiAbstract:Background Bimatoprost 0.03% is associated with increased growth and prominence of eyelashes. Objective We sought to compare the safety and efficacy of once-daily Bimatoprost 0.03% versus vehicle in increasing eyelash length, thickness, and darkness after topical administration to upper eyelid margins. Methods In this 5-month study, subjects were randomized to receive once-daily Bimatoprost 0.03% (n = 137) or vehicle (n = 141). The primary end point was eyelash prominence assessed by the investigator global eyelash assessment scale. Secondary efficacy measures included eyelash length, thickness, and darkness measured by digital image analysis and patient-reported outcomes. Safety data included adverse event monitoring and ophthalmic examinations. Results A higher percentage of subjects treated with Bimatoprost 0.03% (78.1%) versus vehicle (18.4%) demonstrated at least a 1-grade increase in global eyelash assessment score at week 16 ( P P P = .03). Limitations Short-term duration of the trial was a limitation; black subjects were not enrolled secondary to technical requirements of digital image analysis. Conclusion Bimatoprost 0.03% was found to be effective at enhancing eyelashes in adults with a very good safety profile.