E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle Glaucoma and Ocular Hypertension |
Glaucoma ad angolo aperto e Ipertensione oculare |
|
E.1.1.1 | Medical condition in easily understood language |
Glaucoma and increased pressure inside the eye (Ocular hypertension) |
Glaucoma e aumento della pressione all’interno dell’occhio (ipertensione oculare) |
|
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 | 17.1 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
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 |
|
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 |
Valutare l’efficacia e la sicurezza di 2 dosaggi di Bimatoprost SR nel ridurre la pressione intracoulare (IOP) in pazienti con glaucoma ad angolo aperto (OAG) o ipertensione oculare (OHT), dopo somministrazioni iniziali e ripetute |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
Not Applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key 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 |
•È stato ottenuto il consenso informato scritto.
•Secondo il giudizio dello sperimentatore, in base all'uso precedente o all'IOP rebound (rialzo) durante il periodo di washout, il paziente è un responder in termini di riduzione dell'IOP mediante somministrazione topica di prostamidi, prostaglandine o analoghi delle prostaglandine
•L'angolo iridocorneale nella parte inferiore dell'occhio dello studio deve essere confermato come qualificato mediante valutazione AS-OCT del centro di lettura.
•Alla visita iniziale, la densità delle cellule endoteliali centrali in entrambi gli occhi deve essere confermata come qualificata mediante valutazione del centro di lettura
•Diagnosi di OAG (OAG primario, glaucoma pseudoesfoliativo, glaucoma pigmentario) o OHT in ciascun occhio e necessità di trattamento antipertensivo oculare in entrambi gli occhi
•Secondo il giudizio dello sperimentatore, un occhio può essere trattato adeguatamente con collirio a base di timololo come unica terapia
•In entrambi gli occhi, alla visita iniziale: IOP ora 0 ≥ 22 mm Hg e ≤ 32 mm Hg, con una differenza tra gli occhi ≤ 5 mm Hg
•In entrambi gli occhi all'ora 2 della visita iniziale, IOP ≥ 19 mm Hg e ≤ 32 mm Hg |
|
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 |
• Storia di chirurgia per la cataratta nell'occhio dello studio con impianto di lente intraoculare (IOL) nella camera anteriore, IOL fachica, IOL nel solco, afachia o complicanze (per es., lacerazione della capsula posteriore [con o senza perdita vitreale], trauma dell'iride, ecc.)
•Secondo il giudizio dello sperimentatore, il paziente non risponde a betabloccanti oftalmici topici
•Controindicazioni alla terapia con betabloccanti |
|
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). |
Cambiamento rispetto al basale della pressione intraoculare dell’occhio in studio rilevata in relazione al tempo (follow-up meno basale rilevato al tempo corrispondente) ad ogni ora valutata (Ore 0 e 2) |
|
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 |
Il cambiamento medio della IOP rispetto al basale verrà confrontato tra ciascun dosaggio di Bimatoprost SR e timololo per ogni ora (Ore 0 e 2) utilizzando la popolazione ITT. I confronti alla Settimana 12 saranno considerati l’analisi primaria. Le valutazioni della IOP saranno effettuate in 2 momenti: Ora 0 (08:00 ± 1 ora) e Ora 2 (Ora 0 + 2 ore [± 30 min]), e ai Giorni 2, 4 e 8 dopo ogni somministrazione e alle Settimane 2, 6, 12, 15, 18, 22, 28, 31, 34, 38, 44, 48 e 52 |
|
E.5.2 | Secondary end point(s) |
time-matched lowering of IntraOcular Pressure. |
Abbassamento della Pressione Intraoculare rilevato in relazione al tempo |
|
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. |
In occasione delle visite (Settimane 2, 6, e 12) e ore programmate per (1) IOP rilevata in relazione al tempo e (2) cambiamento della IOP rilevata in relazione al tempo rispetto al basale |
|
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 | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 61 |
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 |
Argentina |
Canada |
Colombia |
Czech Republic |
Egypt |
Germany |
Italy |
Korea, Republic of |
Malaysia |
Netherlands |
New Zealand |
Russian Federation |
Saudi Arabia |
Singapore |
South Africa |
Thailand |
Turkey |
United Kingdom |
United States |
|
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
|
|
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |