E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Open-angle Glaucoma and Ocular Hypertension |
|
E.1.1.1 | Medical condition in easily understood language |
Open-angle Glaucoma and Ocular Hypertension |
|
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 | 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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030856 |
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 safety of Bimatoprost SR in patients with OAG or OHT • To evaluate the duration of the IOP-lowering effect of Bimatoprost SR in patients with OAG or OHT |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 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 [US sites] and written Data Protection consent [EU) sites]) 2. Patient has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures 3. Negative pregnancy test at Screening/Enrollment for females of childbearing potential (as defined in Appendix 6) 4. Patients who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and who were: a. Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter) in the eye that received Bimatoprost SR, OR b. Rescued in the eye that received Bimatoprost SR and require additional safety follow-up for that eye based on the investigator’s discretion, OR c. Rescued in the eye that received Bimatoprost SR and require no additional safety follow-up but have clinically significant implant remnants remaining based on the investigator’s judgment OR d. Rescued with topical IOP-lowering medications in the eye that received Bimatoprost SR and are eligible for PRN retreatment in the current study (applicable to patients from lead-in Study 192024-093 Stage 2 only; see Table 4-1) 5. Patients who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and who were: a. Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter ) in the eye that received commercial DURYSTA, OR b. Rescued with topical IOP-lowering medications in the eye that received commercial DURYSTA and are eligible for PRN retreatment in the current study (see Table 4-1) |
|
E.4 | Principal exclusion criteria |
1. Patients who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092 2. Female patients 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 Appendix 6) 3. Concurrent or anticipated enrollment in another investigational drug or device study during the present study 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. Note: the investigator should consider a patient's overall health condition, including COVID-19 infection. This should include assessing if the patient is suspected of; quarantined for; or diagnosed with active COVID-19 infection, and whether or not the patient has any symptoms 6. For patients from the ARGOS lead -in study: history of prior incisional glaucoma surgeries in the study eye or treated fellow eye, including (but not limited to) procedures such as: Ahmed Glaucoma Valve, Baerveldt shunt, Ex -Press glaucoma shunt, Molteno shunt, rabeculectomy, etc; and minimally invasive glaucoma surgical procedures such as (but not limited to): CyPass Micro-Stent, Hydrus, iStent, XEN, et |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• AEs, visual field, visual acuity, macroscopic conjunctival hyperemia, slit-lamp biomicroscopic assessments, dilated ophthalmoscopic assessments (including optic disc assessment), contact ultrasound pachymetry, gonioscopy (implant assessment), and specular microscopy • Key endpoint: time from last Bimatoprost SR treatment in the lead-in study to first rescue treatment or first Bimatoprost SR PRN retreatment Additional variables include: - time from first PRN retreatment to second PRN retreatment regardless of intermittent rescue - time from first PRN retreatment to second PRN retreatment or first rescue treatment time from second PRN retreatment to first rescue treatment - time from SLT treatment in the lead-in study to first rescue treatment in the SLT-treated eye (Phase 3 study comparator) for patients from Study 192024-093 or -095 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Gonioscopic Photography, Anterior Segment Imaging, Ocular Surface Photography, Implant Administration (and/or Removal) Video Recording |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
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 | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 |
Egypt |
Israel |
South Africa |
Austria |
France |
Poland |
Czechia |
Germany |
Italy |
Belgium |
Denmark |
Russian Federation |
Turkey |
United Kingdom |
|
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |