A Double-Masked, Randomized, Parallel Comparison of a Fixed Combination of Bimatoprost 0.03%/Timolol 0.5% with Non-Fixed Combination use in Patients with Glaucoma or Ocular Hypertension

Boone, W. Benton; Branch, James D.; Brigatti, L.; Christie, William C.; Clifford, William S; Cooke, David L.; Corwin, Joel; Davitt, William F.; Burns, Jason L.; Digby, Donald; DiS-clafani, Mark; Dorner, Martin B.; Hommer, Anton; Katzman, Barry; Koch-Schweitzer, Hartwig; Krupin, Theodore; Latina, Mark A.; Lederer, Charles; Leopold, Martin R.; Lesk, Mark R.; Mansouri, Arash; Manusow, David; Murphy, Paul V.; Ochsner, Katherine I.; Otto, Peter; Pfeiffer, Norbert; Piemontesi, Roberto; Protzko, Eugene; Air, Bel; Rubin, Rubin; Rybiczka, R.; Scholzel, Son-ja; Sonty, Sriram; Stewart, Robert H.; Tauber, Joseph; Walters, Thomas R.; Batoosingh, Amy L.; Bossowska, Izabella; Chou, Connie; Ingram, Alison M.; Novack, Gary D.

doi:10.1177/112067210701700108

Cited by 76 publications

(25 citation statements)

References 24 publications

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“…12 Last but not least, it is worthwhile to note that the cost per treatment success in the US, especially at target pressures <15 mmHg, is generally lower for bimatoprost than for either timolol, latanoprost or timolol/dorzolamide. 13 The ocular redness found in two different studies after the fixed combination of bimatoprost 0.03%+0.5% [14][15] was similar to that observed in our patients at the reduced rate of administration of bimatoprost (8.5% vs. 10% of conjunctival hyperaemia and 1.62 vs. 1.8 of hyperaemia grade for the fixed combination and for bimatoprost every 48 hours, respectively). However, there is evidence that in healthy subjects, the duration of conjunctival hyperaemia may be significantly shorter with latanoprost (lasting five days), compared with bimatoprost or travoprost.…”

Section: Discussionsupporting

confidence: 57%

Intraocular Pressure and Conjunctival Hyperaemia with Bimatoprost Every 48 Hours Versus Every 24 Hours

Doro

Paolucci

Cimatti

2009

Journal of Optometry

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PURPOSE:To evaluate the efficacy and tolerability of a reduced rate of bimatoprost administration. METHODS: Diurnal intraocular pressure (IOP) was recorded at 10 a.m., 2 p.m. and 6 p.m. in 40 eyes of twenty Caucasian patients (age range 56-75 years), with ocular hypertension or primary open angle glaucoma, at baseline and four weeks later. The right eye received daily bimatoprost, and in the left eye bimatoprost was administered every 48 hours at 8 p.m. Bulbar conjunctival hyperaemia was assessed by direct observation by a masked observer at baseline and at week 4 and was graded as none, minimal, mild, or moderate or severe (0 to 4). RESULTS: Baseline mean diurnal IOP in the right eye significantly (P<0.001) decreased from 25.4±2.8 to 17.8±1.8 mmHg 14 to 22 hours after daily bimatoprost. Baseline mean diurnal IOP in the left eye significantly (P<0.001) decreased from 25.2±2.0 to 19.0±1.7 mmHg 38 to 46 hours post-dose. The reduction in the right eye was significantly greater than in the left (P=0.02). The average conjunctival hyperaemia after bimatoprost every 24 and 48 hours was graded as 2.4±1.0 and 1.8±0.8 respectively and this difference was significant (P<0.01). CONCLUSION: Bimatoprost every 48 hours was less effective than daily bimatoprost (24.6 vs. 30% IOP decrease), but caused less short term conjunctival hyperaemia. This off label dose schedule may be proposed to patients complaining of ocular redness especially in the first weeks of treatment. RESUMEN OBJETIVO:Evaluar la eficacia y la tolerabilidad de bimatoprost cuando se reduce la frecuencia de administración. MÉTODOS: En 40 ojos pertenecientes a veinte pacientes de raza blanca con hipertensión ocular o con glaucoma primario de ángulo abierto, y con edades comprendidas entre 56 y 75 años, se midió la presión intraocular (PIO) durante el día al inicio del estudio y transcurridas 4 semanas. En el ojo derecho se administró bimatoprost una vez al día (cada 24 horas), y en el ojo izquierdo se administró bimatoprost cada 48 horas, a las 8 p.m. Se evaluó la hiperemia conjuntival bulbar mediante observación directa por parte de un observador (que desconocía la pauta administrada en cada ojo), tanto al inicio del estudio como en la 4ª semana del mismo. La escala utilizada (de 0 a 4) se corresponde con "ausencia de hiperemia", "hiperemia mínima", "hiperemia leve", "hiperemia moderada" o "hiperemia grave". RESULTADOS:Respecto al inicio del estudio, la PIO diurna media en el ojo derecho disminuyó significativamente (P<0,001), pasando de 25,4±2,8 a 17,8±1,8 mmHg, transcurridas entre 14 y 22 horas de la administración diaria de bimatoprost. Respecto al inicio del estudio, la PIO diurna media en el ojo izquierdo disminuyó significativamente (P<0,001), pasando de 25,2±2,0 a 19,0±1,7 mmHg, transcurridas entre 38 y 46 horas de la administración de la dosis. La disminución en el ojo derecho resultó ser significativamente mayor que la observada en el ojo izquierdo (P=0,02). La hiperemia conjuntival promedio, tras administrar bimatoprost cada 24 o cada 48 horas...

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Section: Discussionsupporting

confidence: 57%

Intraocular Pressure and Conjunctival Hyperaemia with Bimatoprost Every 48 Hours Versus Every 24 Hours

Doro

Paolucci

Cimatti

2009

Journal of Optometry

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“…14 We recently published the results of an evaluator-masked, randomized parallel study comparing BTFC administered once daily in the evening vs once-daily evening LTFC in patients with open-angle glaucoma (OAG). 15 Our study found that BTFC demonstrated a superior IOP-lowering effect than LTFC in OAG patients over a period of 4 weeks.…”

Section: Introductionmentioning

confidence: 99%

Bimatoprost/timolol fixed combination vs latanoprost/timolol fixed combination in open-angle glaucoma patients

Martínez

Sánchez

2008

Eye

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Objective To evaluate bimatoprost/timolol fixed combination (BTFC) vs latanoprost/ timolol fixed combination (LTFC) given each evening over the 12-h intraocular pressure (IOP) diurnal curve. Methods A total of 54 eyes of 54 patients (24 with primary open-angle glaucoma (POAG) and 30 with pseudoexfoliative glaucoma (PXG)) were included in this prospective, randomized, evaluator-masked single centre crossover study. Patients with an IOP of X19 mmHg, under treatment with prostaglandin analogues, were randomized to BTFC or LTFC for a 12-week treatment period after a 6-week run-in period on timolol maleate 0.5% (one drop in each eye twice each day). Patients were then switched to the opposite treatment for the second period. Six 12-h IOP curves were recorded for each patient at baseline (under treatment with timolol maleate 0.5% BID), week 6 and 12 for each treatment period. Results The 12-h IOP (mean (SD)) values were 22.0 (1.0) mmHg at baseline, 17.7 (0.8) mmHg on BTFC, and 18.5 (0.8) mmHg on LTFC (Po0.001). At individual time points, there was a significant difference between groups at 0800, 0100, 1200, 1800, and 2000 hours with BTFC having greater ocular hypotensive effect, Po0.001. The most frequently reported adverse event in the study was conjunctival hyperaemia. Average hyperaemia scores were slightly but significantly lower in the LTFC treatment period (P ¼ 0.04). Conclusion This study suggests that the evening-dosed BTFC provides better IOP control than that of LTFC over 12 h. However, the IOP difference was small and may not be clinically meaningful.

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“…Particularmente, los beta-bloqueantes y análo-gos de prostaglandinas tienen mecanismos de acción complementarios, y últimamente, gotas que combinan estas terapias están ganando popularidad (12)(13)(14)(15).…”

Section: Introductionunclassified

Análisis coste-eficacia de las combinaciones fijas de prostaglandinas/prostamida para el tratamiento del glaucoma

Martínez¹,

Slof²

2008

Arch Soc Esp Oftalmol

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RESUMENObjetivo: Evaluar la relación coste-eficacia de las tres combinaciones fijas de prostaglandinas/prostamida con timolol actualmente disponibles en el mercado español [bimatoprost con timolol (BT) -Ganfort ® , latanoprost con timolol (LT) -Xalacom ® y travoprost con timolol (TT) -DuoTrav ® ]. Métodos: Dado que no existen estudios que comparen de una manera directa la eficacia de estos fár-macos, se llevó a cabo una revisión sistemática de la evidencia indirecta en lengua inglesa. Se estimaron el consumo de recursos sanitarios y su coste a partir de un modelo esquemático de la práctica clí-nica habitual en nuestro medio. Se calcularon para cada fármaco la relación coste-eficacia media y la relación coste-eficacia incremental, en términos de euros por punto porcentual de reducción de presión intraocular (PIO) en un periodo de tres meses. Resultados: BT redujo la PIO en un 35,1%, LT en un 35,0% y TT en un 34,7%. El coste-eficacia medio se estimó para BT en 5,34 por punto porcentual de reducción de PIO, para LT en 5,40 , y para TT en 5,45 . El coste-eficacia incremental (coste adicional por punto porcentual adicional de ARTÍCULO ORIGINAL ABSTRACT Objective: To assess the cost-efficacy of three fixed-combination glaucoma treatments currently available in Spain [bimatoprost with timolol (BT)-Ganfort ® , latanoprost with timolol (LT)-Xalacom ® , and travoprost with timolol (TT)-DuoTrav ® ]. Methods: Because no studies are available that give a direct comparison of these drugs, a systematic review was carried out to assess their efficacy. Resource consumption and costs were estimated using a model of usual local practice. For each of the three drugs, average and incremental cost-efficacy ratios were determined in terms of euros per percentage point of reduction of intraocular pressure (IOP) over a three-month period. Results: BT reduced IOP by 35.1%, LT by 35.0% and TT by 34.7%. Average cost-efficacy was estimated to be 5.34 per percentage point of IOP reduction with BT, 5.40 with LT, and 5.45 with TT. Incremental cost-efficacy (incremental cost per incremental percentage point of IOP reduction) was estimated to be 94.65 for LT vs. TT, and was negative for BT vs. TT and BT vs. LT, since in both cases BT was more efficacious and less expensive.

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A Double-Masked, Randomized, Parallel Comparison of a Fixed Combination of Bimatoprost 0.03%/Timolol 0.5% with Non-Fixed Combination use in Patients with Glaucoma or Ocular Hypertension

Cited by 76 publications

References 24 publications

Intraocular Pressure and Conjunctival Hyperaemia with Bimatoprost Every 48 Hours Versus Every 24 Hours

Intraocular Pressure and Conjunctival Hyperaemia with Bimatoprost Every 48 Hours Versus Every 24 Hours

Bimatoprost/timolol fixed combination vs latanoprost/timolol fixed combination in open-angle glaucoma patients

Análisis coste-eficacia de las combinaciones fijas de prostaglandinas/prostamida para el tratamiento del glaucoma

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