Open-angle Glaucoma and Ocular Hypertension MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: LLT Classification code 10030856 Term: Open-angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Bimatoprost SR
Pharmaceutical Form: Implant
INN or Proposed INN: BIMATOPROST
CAS Number: 155206-00-1
Current Sponsor code: AGN-192024
Concentration unit: µg microgram(s)
Concentration ty
Sponsors
Allergan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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;Secondary Objective: Not applicable;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 variable: time to first rescue treatment or Bimatoprost SR PRN retreatment Additional variables: time to first meeting the Bimatoprost SR PRN retreatment criteria in the study eye, time to second meeting the PRN retreatment criteria in study eye after the first PRN retreatment, time to first decision to administer rescue treatment in the SLT-treated eye for patients from Study 192024-093 or -095, number of PRN administrations required in the Bimatoprost SR treated eye in patients eligible for PRN retreatment to maintain effective IOP lowering (in the opinion of the investigator) compared with the SLT-treated eye, and study eye IOP;Timepoint(s) of evaluation of this end point: throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Israel, Italy, Poland, Russian Federation, South Africa, Spain, Turkey, United Kingdom
Contacts
Public ContactCTRG
Allergan Ltd.
Outcome results
None listed