E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle Glaucoma and Ocular Hypertension |
Glaucoma de ángulo abierto (GAA) e hipertensión ocular (HTO) |
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E.1.1.1 | Medical condition in easily understood language |
Glaucoma and increased pressure inside the eye (Ocular hypertension) |
Glaucoma y aumento de la presión dentro del ojo (hipertensión ocular) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10018307 |
E.1.2 | Term | Glaucoma and ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030043 |
E.1.2 | Term | Ocular hypertension |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 2 dose strengths of Bimatoprost SR in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) after initial and repeated administrations |
Evaluar la presión intraocular (IOP) -reducción de eficacia y seguridad de 2 concentraciones de dosis de Bimatoprost SR en pacientes con glaucoma de ángulo abierto (OAG) o hipertensión ocular (OHT) tras administraciones iniciales y repetidas |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Written informed consent has been obtained - In the opinion of the investigator, based on prior use or on IOP rebound (elevation) during the washout period, patient is a responder to IOP lowering by topical prostamides, prostaglandins, or prostaglandin analogs -The iridocorneal angle inferiorly in the study eye must be confirmed as being qualified by Reading Center AS-OCT assessment -By the Baseline visit, the final central endothelial cell density in both eyes must be confirmed as being qualified by Reading Center assessment - Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, and both eyes require IOP-lowering treatment - In the investigator´s opinion, either eye can be treated adequately with timolol eye drops as the sole therapy- In both eyes, at the baseline visit: Hour 0 IOP of >= 22 mm Hg and <= 32 mm Hg, with difference between eyes of <= 5 mm Hg - In both eyes at Hour 2 at the baseline visit, IOP >= 19 mm Hg and <= 32 mm Hg |
- Se ha obtenido el consentimiento informado por escrito. - En opinión del investigador, basada en un uso anterior o en un rebote de la PIO (elevación) durante el periodo de lavado, el paciente responde favorablemente a prostamidas, prostaglandina o análogos de las prostaglandinas de uso tópico. - El centro de lectura debe confirmar la elegibilidad del ángulo iridocorneal en la parte inferior del ojo del estudio mediante AS-OCT. - Para la visita basal, el centro de lectura debe haber confirmado la elegibilidad de la densidad celular endotelial central final de ambos ojos. - Diagnóstico de GAA (GAA primario, glaucoma pseudoexfoliativo o glaucoma pigmentario) o de HTO en los dos ojos y que ambos ojos requieran tratamiento para la reducción del la PIO. - En opinión del investigador, los dos ojos se pueden tratar de forma adecuada con colirio de timolol como único tratamiento. - En la visita basal, hora 0, la PIO de ambos ojos tiene un valor entre >=22 mm Hg y <=32 mm Hg, con una diferencia entre los dos ojos de <=5 mm Hg. - En ambos ojos, en la hora 2 de la visita basal, la PIO es >=19 mm Hg y <=32 mm Hg. |
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E.4 | Principal exclusion criteria |
- History of cataract surgery in the study eye resulting in anterior chamber intraocular lens implant (IOL), phakic IOL, sulcus IOL, aphakia, or complications (eg, a posterior capsular tear [with or without vitreous loss], iris trauma, etc) - In the investigator´s opinion, patient is nonresponsive to topical ophthalmic beta-blockers - Contraindications to beta-blocker therapy |
-Antecedentes de cirugía de cataratas en el ojo del estudio con implante de lente intraocular (LIO) en la cámara anterior, LIO fáquico, LIO en sulcus, afaquia o complicaciones (por ejemplo, desgarro de la cápsula posterior [con o sin pérdida del humor vítreo], traumatismo del iris, etc). - En opinión del investigador, el paciente no responde a betabloqueantes oftálmicos tópicos. - Contraindicaciones a tratamiento con betabloqueantes. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Study eye time-matched IntraOcular Pressure change from baseline (follow-up minus time-matched baseline) at each hour evaluated (Hours 0 and 2). |
Cambios de la Presión Intraocular en punto de referencia temporal desde basal (seguimientos desde basal menos el punto de referencia) en las horas evaluadas ( hora 0 y hora 2). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Mean IOP change from baseline will be compared between each Bimatoprost SR dose strength and timolol for each hour (Hours 0 and 2) using the ITT population. The comparisons at Week 12 will be considered the primary analysis. IOP evaluations will occur at 2 timepoints: Hour 0 (08:00 ± 1 hour) and Hour 2 (Hour 0 + 2 hours [± 30 min]), and on Days 2; 4 and 8 after each administration and at Weeks 2, 6, 12, 15, 18, 22, 28, 31, 34, 38, 44, 48, and 52 |
Cambio de PIO desde visita basal comparando Bimatoprost SR en cada concetración de dosis y timolol por cada hora (horas 0 y 2) el uso de la población ITT. Las comparaciones en la semana 12 se tendrán en cuenta el análisis primario. Evaluaciones de la PIO se producirán en 2 puntos de tiempo: 0 horas (8:00 ± 1 hora) y 2 horas (hora 0 + 2 horas [± 30 min]), y en los días 2; 4 y 8 después de cada administración y en las semanas 2, 6, 12, 15, 18, 22, 28, 31, 34, 38, 44, 48, y 52 |
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E.5.2 | Secondary end point(s) |
time-matched lowering of IntraOcular Pressure. |
Reduccion de la presion intraocular coincidente en el tiempo. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at scheduled visits (Weeks 2, 6, and 12) and hours for (1) time-matched IOP and (2) time-matched IOP change from baseline. |
en las visitas programadas (semanas 2, 6 y 12) y horas para (1) PIO coincidente en el tiempo y (2) el PIO coincidente en el tiempo desde visita basal. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Austria |
Belgium |
Brazil |
Chile |
Denmark |
France |
Hong Kong |
Hungary |
Israel |
Peru |
Philippines |
Poland |
Spain |
Switzerland |
Taiwan |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |