Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brimo PS DDS® 400 μg (2 implants) | Experimental | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. |
|
| Brimo PS DDS® 400 μg (1 implant) | Experimental | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. |
|
| Brimo PS DDS® 200 μg (2 implants) | Experimental | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. |
|
| Brimo PS DDS® 200 μg (1 implant) | Experimental | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. |
|
| Brimo PS DDS® 100 μg (1 implant) | Experimental | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. |
|
| Brimo PS DDS® 50 μg (1 implant) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimo PS DDS® | Drug | Patients who received Brimo PS DDS® intravitreal implant in a previous study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With No Visible Implants in the Study Eye | Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study. | Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Vision Loss in the Study Eye | Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | United States | ||||
Patients enrolled in this extension study from the following parent studies: 190342-027D, 190342-028D, 190342-030D, 190342-031D, 190342-032D, and 190342-036. No treatment was administered in this study, so the treatment groups reflect the treatments received in the parent studies.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brimo PS DDS® 400 μg (2 Implants) | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. |
| FG001 | Brimo PS DDS® 400 μg (1 Implant) | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. |
|
| Sham | Sham Comparator | Patients who received sham in a previous study. |
|
| Sham | Other | Patients who recieved sham in a previous study. |
|
| Baseline of Parent Study, Month 36 |
| Sydney |
| New South Wales |
| Australia |
| Westmead | New South Wales | Australia |
| Brno | Czechia |
| Paris | France |
| Karlsruhe | Germany |
| New Delhi | New Delhi | India |
| Tel Aviv | Israel |
| Udine | Italy |
| Makati | Philippines |
| Coimbra | Portugal |
| Seoul | South Korea |
| London | United Kingdom |
| FG002 | Brimo PS DDS® 200 μg (2 Implants) | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. |
| FG003 | Brimo PS DDS® 200 μg (1 Implant) | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. |
| FG004 | Brimo PS DDS® 100 μg (1 Implant) | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. |
| FG005 | Brimo PS DDS® 50 μg (1 Implant) | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. |
| FG006 | Sham | Patients who received sham in a previous study. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brimo PS DDS® 400 μg (2 Implants) | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. |
| BG001 | Brimo PS DDS® 400 μg (1 Implant) | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. |
| BG002 | Brimo PS DDS® 200 μg (2 Implants) | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. |
| BG003 | Brimo PS DDS® 200 μg (1 Implant) | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. |
| BG004 | Brimo PS DDS® 100 μg (1 Implant) | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. |
| BG005 | Brimo PS DDS® 50 μg (1 Implant) | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. |
| BG006 | Sham | Patients who received sham in a previous study. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With No Visible Implants in the Study Eye | Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study. | Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study | Posted | Number | Patients | Month 36 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Vision Loss in the Study Eye | Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment. | Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study | Posted | Number | Patients | Baseline of Parent Study, Month 36 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brimo PS DDS® 400 μg (2 Implants) | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. | 8 | 28 | 13 | 28 | ||
| EG001 | Brimo PS DDS® 400 μg (1 Implant) | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. | 11 | 53 | 30 | 53 | ||
| EG002 | Brimo PS DDS® 200 μg (2 Implants) | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. | 7 | 33 | 17 | 33 | ||
| EG003 | Brimo PS DDS® 200 μg (1 Implant) | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. | 7 | 42 | 25 | 42 | ||
| EG004 | Brimo PS DDS® 100 μg (1 Implant) | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. | 2 | 6 | 4 | 6 | ||
| EG005 | Brimo PS DDS® 50 μg (1 Implant) | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. | 0 | 2 | 2 | 2 | ||
| EG006 | Sham | Patients who received sham in a previous study. | 16 | 51 | 26 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Age-Related Macular Degeneration | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Enterocele | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Sudden Cardiac Death | General disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Cardio-respiratory Arrest | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Rectal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Retinal Vein Occlusion | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Anterior Chamber Inflammation | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Non-Hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Open Angle Glaucoma | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Peripheral Artery Stenosis | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Peripheral Vascular Disorder | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Prostate Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Colorectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Intermittent Claudication | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Jaw Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Systematic Assessment |
| |
| Oesophagitis Ulcerative | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Pubis Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Optic Atrophy | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
| |
| Haemorrhagic Stroke | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Age-Related Macular Degeneration | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Vitreous Detachment | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Vitreous Floaters | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Retinal Haemorrhage | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Posterior Capsule Opacification | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Intraocular Pressure Increased | Investigations | MedDRA version 17.0 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Macular Fibrosis | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Optic Disc Haemorrhage | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Macular Degeneration | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Glare | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Cataract Cortical | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Otitis Media Chronic | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
| |
| Restless Legs Syndrome | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Stress Urinary Incontinence | Renal and urinary disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA version 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
| |
| Cataract Subscapular | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
| Between 65 and 84 years |
|
| ≥85 years |
|
| Male |
|
| OG003 | Brimo PS DDS® 200 μg (1 Implant) | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. |
| OG004 | Brimo PS DDS® 100 μg (1 Implant) | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. |
| OG005 | Brimo PS DDS® 50 μg (1 Implant) | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. |
| OG006 | Sham | Patients who received sham in a previous study. |
|
|