E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle glaucoma (OAG) or Ocular hypertension (OHT) |
Glaucoma de ángulo abierto (GAA) o Hipertensión ocular (HO) |
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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 intraocular (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 | 19.0 |
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 | 19.0 |
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 | 19.0 |
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 IOP-lowering effect and safety of Bimatoprost SR compared with SLT in patients with OAG or OHT, who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence). |
Evaluar el efecto reductor de la presión intraocular (PIO) y la seguridad de Bimatoprost LP, en comparación con la trabeculoplastia selectiva con láser (TSL), en pacientes con glaucoma de ángulo abierto (GAA) o hipertensión ocular (HO) no controlados adecuadamente con medicamentos tópicos para la reducción de la PIO por causas distintas a la eficacia de la medicación (es decir, no se debe a intolerancia ni a incumplimiento terapéutico) |
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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 |
1. Male or female, 18 years of age or older; 2. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (e.g., Written Authorization for Use and Release of Health and Research Study Information [United States (US) sites] and written Data Protection consent [European Union (EU) sites]) 3. In the investigator’s opinion, patient’s IOP is not adequately managed with topical medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence)
Both Eyes 1. In the investigator’s opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (e.g., LUMIGAN, Xalatan®, Travatan®) eye drops as the sole therapy if medication was taken as directed; 2. In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy; 3. In the investigator’s opinion, patient is a suitable candidate for SLT; 4. Diagnosis of either OAG (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in each eye, requiring bilateral IOP-lowering treatment (Note: diagnosis does not have to be the same in both eyes); 5. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout; 6. The iridocorneal angle inferiorly must be confirmed as being qualified by Reading Center anterior segment optical coherence tomography assessment prior to beginning Washout; 7. At the Baseline visit (8:00 AM ± 1 hour), IOP of >/= 22 and </= 34 mm Hg, with difference between eyes of </= 5 mm Hg. |
1. Hombre o mujer de 18 años de edad o mayor 2. Se obtienen el consentimiento informado escrito y la autorización para utilizar y divulgar información sanitaria personal de conformidad con los requisitos de privacidad locales y nacionales, cuando proceda (p. ej. autorización escrita para el uso y la divulgación de información sanitaria y del estudio de investigación [centros de Estados Unidos (EE. UU.)] y consentimiento de protección de datos por escrito [Unión Europea (UE)]) 3. En opinión del investigador, la PIO del paciente no está controlada adecuadamente con la medicación tópica por causas distintas a la eficacia de la medicación (ej, debido a intolerancia o al incumplimiento terapéutico)
Ambos ojos 1. En opinión del investigador, ambos ojos pueden tratarse adecuadamente con colirios de prostamida, prostaglandina o análogo de las prostaglandinas (p. ej., LUMIGAN, Xalatan, Travatan), como único tratamiento si la medicación se toma del modo indicado; 2. En opinión del investigador, la PIO del paciente puede controlarse adecuadamente con monoterapia con TSL; 3. En opinión del investigador, el paciente es un candidato idóneo para la TSL; 4. Diagnóstico de GAA (es decir, GAA primaria, glaucoma pseudoexfoliativo, glaucoma pigmentario) o HO en ambos ojos, requiriéndose tratamiento bilateral reductor de la PIO. (Nota: el diagnóstico no tiene que ser necesariamente el mismo para ambos ojos); 5. Densidad de células endoteliales centrales por microscopia especular confirmada como apta mediante la evaluación en el Centro de lectura antes de iniciarse el reposo farmacológico; 6. Debe confirmarse que el ángulo iridocorneal inferior es apto mediante la evaluación por tomografía de coherencia óptica del segmento anterior en el Centro de lectura, antes de iniciarse el reposo farmacológico; 7. En la visita inicial (08:00 ± 1 hora), PIO >/= 22 y </= 34 mm Hg, con diferencia entre ojos </= 5 mm Hg |
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E.4 | Principal exclusion criteria |
Both Eyes • History of previous laser trabeculoplasty • History of cataract surgery resulting in anterior chamber (AC) intraocular lens (IOL) implant, phakic IOL, sulcus IOL, aphakia, or complications (e.g., a posterior capsular tear [with or without vitreous loss], iris trauma, etc.) |
Ambos ojos • Antecedentes de trabeculoplastia con láser previa • Antecedentes de cirugía para cataratas que resultase en implante de lente intraocular (LIO) en la CA, LIO fáquica, LIO en surco, afaquia o complicaciones (p. ej., ruptura de cápsula posterior [con o sin pérdida vítrea], traumatismo del iris, etc.) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is IOP change from baseline and the primary time period is 24 weeks |
La variable principal de la eficacia es la variación de la PIO con respecto al inicio, siendo el período de tiempo principal de 24 semanas |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Weeks 4, 12, and 24 |
Semanas 4, 12 y 24 |
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E.5.2 | Secondary end point(s) |
Secondary efficacy variables to compare Bimatoprost SR eyes and SLT eyes include: 1) IOP change from baseline time-weighted average through Week 24 2) IOP changes from baseline at Weeks 8, 15, and 20 3) Raw IOP at each visit 4) Time to onset of effect (time to first achieving >/= 20% IOP reduction) 5) Time to initial use of nonstudy IOP-lowering treatment (as determined by the investigator) 6) Percentage of Bimatoprost SR and SLT eyes achieving >/= 20% reduction by visit |
Las variables secundarias de la eficacia para comparar los ojos con Bimatoprost LP y con TSL incluyen: 1) Variación de la PIO en la semana 24 con respecto a la media inicial ponderada por tiempo 2) Las variaciones de la PIO en las semanas 8, 15 y 20 con respecto al inicio 3) PIO bruta de cada visita 4) Tiempo hasta el inicio del efecto (tiempo transcurrido hasta alcanzar por primera vez una reducción de la PIO >/= 20%) 5) Tiempo hasta el uso inicial de medicamentos reductores de la PIO no pertenecientes al estudio (como lo determine el investigador) 6) Porcentaje de ojos con Bimatoprost LP o TSL que alcanzan una reducción >/= 20% por visita |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1), 5) - Study duration 2) - Weeks 8, 15, and 20 3), 6) - Each visit 4) - Time to first achieving >/= 20% IOP reduction |
1), 5) -Duración del estudio 2) - Semanas 8, 15 y 20 3), 6) - Cada visita 4) - tiempo transcurrido hasta alcanzar por primera vez una reducción de la PIO >/= 20% |
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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 | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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 |
Belgium |
Czech Republic |
France |
Italy |
Poland |
Russian Federation |
Singapore |
Spain |
Thailand |
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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The End of trial is defined by the last patient last visit (LPLV). |
El fin de ensayo se define como la última visita del último paciente. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 30 |