E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle Glaucoma and Ocular Hypertension |
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E.1.1.1 | Medical condition in easily understood language |
Glaucoma and increased pressure inside the eye (ocular hypertension) |
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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 | 20.0 |
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 | 20.0 |
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 | 20.0 |
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 effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT), who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence). |
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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 |
• Male or female, 18 years of age or older • 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 (eg, 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]) • In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence) Ocular • In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan® , Travatan® ) eye drops as the sole therapy if medication was taken as directed • In the investigator's opinion, patient's IOP can be adequately managed with SLT monotherapy • In the investigator's opinion, patient is a suitable candidate for SLT • Diagnosis of either OAG (ie, 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) • Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout • The iridocorneal angle must be independently confirmed as being qualified by 2 ophthalmologists using the following criteria: o Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle o Peripheral anterior chamber depth by Van Herick examination ≥ 1/2 corneal thickness Note: The independent eligibility assessments must both agree that the Shaffer grade is ≥ 3 and the Van Herick grade is ≥ 1/2 corneal thickness. • At the Baseline visit (8:00 AM ± 1 hour), IOP of ≥ 22 and ≤ 34 mm Hg, with difference between eyes of ≤ 5 mm Hg |
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E.4 | Principal exclusion criteria |
Ocular • History of previous laser trabeculoplasty • The following surgical history: a. History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant (IOL; sulcus IOL; aphakia etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) Note: history of uncomplicated cataract surgery is not an exclusion. b. History of phakic IOL insertion for refractive error correction
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: The primary efficacy variable is IOP change from baseline (follow up value minus baseline value) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) Time to initial use of nonstudy IOP-lowering treatment (as determined by the investigator) 2) Percentage of Bimatoprost SR and SLT eyes achieving ≥ 20% reduction in IOP from baseline 3) IOP changes from baseline at Weeks 8, 15, and 20
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Study duration 2) Each Visit 3) Weeks 8, 15, and 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 | No |
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 |
paired-eye, efficacy evaluator-masked |
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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 | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Selective Laser Trabeculoplasty (SLT) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
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 |
Canada |
Denmark |
Germany |
Israel |
New Zealand |
Philippines |
Poland |
Russian Federation |
United Kingdom |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 6 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 30 |