E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle glaucoma (OAG) or Ocular hypertension (OHT) |
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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 | 100000004853 |
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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 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). |
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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. Patient is willing to withhold his/her IOP treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk. Note: If patients cannot discontinue their currently prescribed therapy for up to 6 weeks to meet the Washout period for study entry., the investigator may switch the patient's medication to one that requires a shorter washout interval during the washout of the original medication (see Section 8.2 and Table 6 in the protocol)
4. Patient has the ability to understand and the willingness to follow study instructions and requirements and is likely to complete all required visits and procedures
5. 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)
6. Negative pregnancy test at Baseline for females of childbearing potential
Both Eyes
7. 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;
8. In the investigator’s opinion, patient’s IOP can be adequately managed with SLT monotherapy
9. In the investigator’s opinion, patient is a suitable candidate for SLT
10. 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);
11. Central endothelial cell density by specular microscopy confirmed as being qualified by Reading Center assessment prior to beginning Washout
12. The iridocorneal angle must be independently confirmed as being qualified by 2 ophthalmologists using the following critetia: a. Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle b. 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
13. At the Baseline visit, patient has been appropriately washed out of all IOP-lowering medications
14. At the Baseline visit (8:00 AM ± 1 hour), IOP of ≥ 22 and ≤ 34 mm Hg, with difference between eyes of ≤ 5 mm Hg.
15. At the Screening and Baseline (Day -3 to -1) visits, Best-Corrected Visual Acuity (Snellen equivalent, by manifest refraction) of 20/50 or better in each eye. |
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E.4 | Principal exclusion criteria |
1. Uncontrolled systemic disease
2. Females who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study (see Section 4.5.3 of the protocol)
3. Known allergy or sensitivity to the study medication or its components, any component of the delivery vehicle, or any diagnostic or surgical prep agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine)
4. Any condition which would preclude the patient's ability to comply with study requirements (including completion of the study)
5. Patients who have a condition or are in a situation, which, in the investigator's opinion, may put the patient at significant risk, may
confound the study results, or may interfere significantly with the patient's participation in the study
6. Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study from 2 months prior to the Baseline visit through the final study visit
7. Previous or concurrent enrollment in another Allergan Bimatoprost SR
study
8. Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator). Note: Patients receiving pharmacologic blood thinners (eg, aspirin, Coumadin) may be enrolled at
the investigator's discretion.
Ocular Exclusion Criteria for Both Eyes:
9. History of previous laser trabeculoplasty
10. History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc)
11. 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
12. Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment (Day 1)
13. Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty [DSEK], Descemet's Membrane Endothelial Keratoplasty [DMEK]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions
14. Corneal or other ocular abnormalities that would preclude accurate readings with an applanation tonometer, anterior segment-optical coherence tomography, specular microscope, and/or a contact
pachymeter, or could confound study results, eg, moderate to severe corneal dystrophy, including Anterior Basement Membrane Disease (ABMD; ie, Map-Dot-Fingerprint [MDF]) and guttata. Mild ABMD or mild
guttata are not exclusionary by clinical examination if, in the opinion of the investigator, the condition is stable and not likely to cause corneal changes during the
course of the study.
15. Active or recurrent ocular disease (eg, uveitis, ocular infection, chronic moderate to severe blepharitis or severe dry eye, severe ocular seasonal allergies) or sight threatening diseases (eg, neovascular agerelated
macular degeneration [ARMD], diabetic macular edema) that, in the opinion of the investigator, would put the patient at a significant risk or would interfere with the interpretation of the study data. Patients
with slowly progressive eye diseases (ie, mild cataracts, nonneovascular ARMD) can be enrolled at the discretion of the investigator.
16. Any history of external ocular or intraocular malignancy, and/or any history of benign ocular neoplasia that in the investigator's opinion resulted in clinically significant ocular morbidity
17. History of herpetic ocular diseases (including herpes simplex virus and varicella zoster virus)
18. The following ocular surface findings:
a. Bulbar conjunctival hyperemia, on either macroscopic or slit-lamp examination, > +1 (mild) at baseline b. Active ocular surface findings other than bulbar conjunctival
hyperemia, on either macroscopic or slit-lamp examination, > +1 (mild) at Baseline
19. History of moderate or worse (≥ +2) bulbar conjunctival hyperemia due to marketed prostaglandin, prostamide, or prostaglandin analog use
For Exclusion criteria 20 to 30 please see protocol
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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 |
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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) |
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 |
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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 |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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). |
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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 | |
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 |