Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01080209
Collaborator
(none)
215
13
7
48
16.5
0.3
Study Details
Study Description
Brief Summary
This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
215 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Feb 1, 2014
Actual Study Completion Date
:
Feb 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brimo PS DDS® 400 μg (2 implants) Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. |
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
|
| Experimental: Brimo PS DDS® 400 μg (1 implant) Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. |
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
|
| Experimental: Brimo PS DDS® 200 μg (2 implants) Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. |
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
|
| Experimental: Brimo PS DDS® 200 μg (1 implant) Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. |
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
|
| Experimental: Brimo PS DDS® 100 μg (1 implant) Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. |
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
|
| Experimental: Brimo PS DDS® 50 μg (1 implant) Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. |
Drug: Brimo PS DDS®
Patients who received Brimo PS DDS® intravitreal implant in a previous study.
|
| Sham Comparator: Sham Patients who received sham in a previous study. |
Other: Sham
Patients who recieved sham in a previous study.
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With No Visible Implants in the Study Eye [Month 36]
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.
Secondary Outcome Measures
- Number of Patients With Vision Loss in the Study Eye [Baseline of Parent Study, Month 36]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason
-
Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Artesia | California | United States | ||
| 2 | Sydney | New South Wales | Australia | ||
| 3 | Westmead | New South Wales | Australia | ||
| 4 | Brno | Czech Republic | |||
| 5 | Paris | France | |||
| 6 | Karlsruhe | Germany | |||
| 7 | New Delhi | India | |||
| 8 | Tel Aviv | Israel | |||
| 9 | Udine | Italy | |||
| 10 | Seoul | Korea, Republic of | |||
| 11 | Makati | Philippines | |||
| 12 | Coimbra | Portugal | |||
| 13 | London | United Kingdom |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01080209
Other Study ID Numbers:
- 190342-033D
First Posted:
Mar 4, 2010
Last Update Posted:
Feb 20, 2015
Last Verified:
Feb 1, 2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. | Patients who received sham in a previous study. |
| Period Title: Overall Study | |||||||
| STARTED | 28 | 53 | 33 | 42 | 6 | 2 | 51 |
| COMPLETED | 22 | 42 | 28 | 37 | 6 | 2 | 44 |
| NOT COMPLETED | 6 | 11 | 5 | 5 | 0 | 0 | 7 |
Baseline Characteristics
| Arm/Group Title | Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. | Patients who received sham in a previous study. | Total of all reporting groups |
| Overall Participants | 28 | 53 | 33 | 42 | 6 | 2 | 51 | 215 |
| Age, Customized (Number) [Number] | ||||||||
| 18 to 64 years |
2
7.1%
|
23
43.4%
|
3
9.1%
|
20
47.6%
|
3
50%
|
0
0%
|
20
39.2%
|
71
33%
|
| Between 65 and 84 years |
19
67.9%
|
29
54.7%
|
24
72.7%
|
19
45.2%
|
3
50%
|
1
50%
|
26
51%
|
121
56.3%
|
| ≥85 years |
7
25%
|
1
1.9%
|
6
18.2%
|
3
7.1%
|
0
0%
|
1
50%
|
5
9.8%
|
23
10.7%
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
19
67.9%
|
24
45.3%
|
17
51.5%
|
20
47.6%
|
3
50%
|
2
100%
|
21
41.2%
|
106
49.3%
|
| Male |
9
32.1%
|
29
54.7%
|
16
48.5%
|
22
52.4%
|
3
50%
|
0
0%
|
30
58.8%
|
109
50.7%
|
Outcome Measures
| Title | Number of Patients With No Visible Implants in the Study Eye |
|---|---|
| Description | 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. |
| Time Frame | Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study |
| Arm/Group Title | Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. | Patients who received sham in a previous study. |
| Measure Participants | 23 | 42 | 30 | 37 | 6 | 2 | 46 |
| Number [Patients] |
14
|
37
|
26
|
35
|
6
|
2
|
46
|
| Title | Number of Patients With Vision Loss in the Study Eye |
|---|---|
| Description | 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. |
| Time Frame | Baseline of Parent Study, Month 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study |
| Arm/Group Title | Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. | Patients who received sham in a previous study. |
| Measure Participants | 23 | 42 | 30 | 37 | 6 | 2 | 46 |
| Severe Vision Loss |
3
|
1
|
1
|
0
|
0
|
0
|
4
|
| Moderate Vision Loss |
6
|
0
|
6
|
1
|
0
|
0
|
6
|
| No or Mild Vision Loss |
14
|
41
|
23
|
36
|
6
|
2
|
36
|
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham | |||||||
| Arm/Group Description | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. | Patients who received sham in a previous study. | |||||||
All Cause Mortality |
||||||||||||||
| Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/28 (28.6%) | 11/53 (20.8%) | 7/33 (21.2%) | 7/42 (16.7%) | 2/6 (33.3%) | 0/2 (0%) | 16/51 (31.4%) | |||||||
| Cardiac disorders | ||||||||||||||
| Atrial Fibrillation | 1/28 (3.6%) | 1/53 (1.9%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Angina Pectoris | 1/28 (3.6%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Atrioventricular Block Second Degree | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Cardio-respiratory Arrest | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Palpitations | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Acute Myocardial Infarction | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Coronary Artery Disease | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Myocardial Infarction | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Eye disorders | ||||||||||||||
| Age-Related Macular Degeneration | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Visual Acuity Reduced | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Retinal Detachment | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Retinal Vein Occlusion | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Anterior Chamber Inflammation | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Open Angle Glaucoma | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Optic Atrophy | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Enterocele | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Oesophagitis Ulcerative | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| General disorders | ||||||||||||||
| Death | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Sudden Cardiac Death | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Cholelithiasis | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Clostridium Difficile Colitis | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Gangrene | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Pneumonia | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Urinary Tract Infection | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Toxicity to Various Agents | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Hip Fracture | 0/28 (0%) | 0/53 (0%) | 2/33 (6.1%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Humerus Fracture | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Spinal Compression Fracture | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 2/51 (3.9%) | |||||||
| Ankle Fracture | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Facial Bones Fracture | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Fall | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Jaw Fracture | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Pubis Fracture | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Tibia Fracture | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Upper Limb Fracture | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Femur Fracture | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Diabetic Ketoacidosis | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Intervertebral Disc Protrusion | 1/19 (5.3%) | 0/24 (0%) | 0/17 (0%) | 1/20 (5%) | 0/3 (0%) | 0/2 (0%) | 0/21 (0%) | |||||||
| Lumbar Spinal Stenosis | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Osteoarthritis | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||
| Bladder Cancer | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Lung Cancer Metastatic | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Lung Neoplasm Malignant | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Rectal Adenocarcinoma | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Non-Hodgkin's Lymphoma | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Hepatocellular Carcinoma | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Prostate Cancer | 0/9 (0%) | 0/29 (0%) | 0/16 (0%) | 1/22 (4.5%) | 0/3 (0%) | 0/0 (NaN) | 0/30 (0%) | |||||||
| Renal Cancer | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Prostate Cancer Recurrent | 0/9 (0%) | 0/29 (0%) | 0/16 (0%) | 0/22 (0%) | 1/3 (33.3%) | 0/0 (NaN) | 0/30 (0%) | |||||||
| Basal Cell Carcinoma | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Bladder Transitional Cell Carcinoma | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Breast Cancer Metastatic | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Colorectal Cancer | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Oesophageal Carcinoma | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Nervous system disorders | ||||||||||||||
| Cerebrovascular Accident | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Syncope | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Haemorrhagic Stroke | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Nephrolithiasis | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Reproductive system and breast disorders | ||||||||||||||
| Cystocele | 1/19 (5.3%) | 0/24 (0%) | 0/17 (0%) | 0/20 (0%) | 0/3 (0%) | 0/2 (0%) | 0/21 (0%) | |||||||
| Rectocele | 1/19 (5.3%) | 0/24 (0%) | 0/17 (0%) | 0/20 (0%) | 0/3 (0%) | 0/2 (0%) | 0/21 (0%) | |||||||
| Benign Prostatic Hyperplasia | 0/9 (0%) | 1/29 (3.4%) | 0/16 (0%) | 0/22 (0%) | 0/3 (0%) | 0/0 (NaN) | 0/30 (0%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Pulmonary Embolism | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Dyspnoea Exertional | 0/28 (0%) | 1/53 (1.9%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Deep Vein Thrombosis | 1/28 (3.6%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Peripheral Artery Stenosis | 0/28 (0%) | 0/53 (0%) | 1/33 (3%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Peripheral Ischaemia | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Peripheral Vascular Disorder | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 1/42 (2.4%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Hypertension | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
| Intermittent Claudication | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 1/51 (2%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Brimo PS DDS® 400 μg (2 Implants) | Brimo PS DDS® 400 μg (1 Implant) | Brimo PS DDS® 200 μg (2 Implants) | Brimo PS DDS® 200 μg (1 Implant) | Brimo PS DDS® 100 μg (1 Implant) | Brimo PS DDS® 50 μg (1 Implant) | Sham | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/28 (46.4%) | 30/53 (56.6%) | 17/33 (51.5%) | 25/42 (59.5%) | 4/6 (66.7%) | 2/2 (100%) | 26/51 (51%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Anaemia | 2/28 (7.1%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 3/51 (5.9%) | |||||||
| Cardiac disorders | ||||||||||||||
| Coronary Artery Disease | 2/28 (7.1%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Bradycardia | 2/28 (7.1%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Acute Coronary Syndrome | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Ear Pain | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Endocrine disorders | ||||||||||||||
| Hypothyroidism | 2/28 (7.1%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Eye disorders | ||||||||||||||
| Cataract | 3/28 (10.7%) | 6/53 (11.3%) | 0/33 (0%) | 6/42 (14.3%) | 0/6 (0%) | 0/2 (0%) | 6/51 (11.8%) | |||||||
| Visual Acuity Reduced | 3/28 (10.7%) | 3/53 (5.7%) | 3/33 (9.1%) | 5/42 (11.9%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Age-Related Macular Degeneration | 2/28 (7.1%) | 0/53 (0%) | 3/33 (9.1%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Vitreous Detachment | 2/28 (7.1%) | 0/53 (0%) | 2/33 (6.1%) | 4/42 (9.5%) | 0/6 (0%) | 0/2 (0%) | 4/51 (7.8%) | |||||||
| Vitreous Floaters | 0/28 (0%) | 5/53 (9.4%) | 3/33 (9.1%) | 3/42 (7.1%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Retinal Haemorrhage | 0/28 (0%) | 0/53 (0%) | 2/33 (6.1%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Posterior Capsule Opacification | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 4/51 (7.8%) | |||||||
| Dry Eye | 0/28 (0%) | 5/53 (9.4%) | 2/33 (6.1%) | 4/42 (9.5%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Macular Fibrosis | 0/28 (0%) | 4/53 (7.5%) | 0/33 (0%) | 3/42 (7.1%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Optic Disc Haemorrhage | 0/28 (0%) | 3/53 (5.7%) | 2/33 (6.1%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Glaucoma | 0/28 (0%) | 3/53 (5.7%) | 0/33 (0%) | 4/42 (9.5%) | 0/6 (0%) | 0/2 (0%) | 5/51 (9.8%) | |||||||
| Macular Degeneration | 0/28 (0%) | 3/53 (5.7%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Blepharitis | 0/28 (0%) | 0/53 (0%) | 2/33 (6.1%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Glare | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 1/2 (50%) | 0/51 (0%) | |||||||
| Cataract Cortical | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 3/42 (7.1%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Cataract Subscapular | 0/28 (0%) | 4/53 (7.5%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Constipation | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 3/51 (5.9%) | |||||||
| Dysphagia | 0/28 (0%) | 0/53 (0%) | 2/33 (6.1%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Gastrooesophageal Reflux Disease | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Dental Caries | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Diarrhoea | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Nasopharyngitis | 0/28 (0%) | 3/53 (5.7%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Urinary Tract Infection | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Pneumonia | 0/28 (0%) | 3/53 (5.7%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Influenza | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Otitis Media Chronic | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Investigations | ||||||||||||||
| Intraocular Pressure Increased | 0/28 (0%) | 6/53 (11.3%) | 0/33 (0%) | 4/42 (9.5%) | 0/6 (0%) | 0/2 (0%) | 4/51 (7.8%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Hypercholesterolaemia | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 2/2 (100%) | 0/51 (0%) | |||||||
| Gout | 0/28 (0%) | 0/53 (0%) | 2/33 (6.1%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Diabetes Mellitus Inadequate Control | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 1/2 (50%) | 0/51 (0%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Arthralgia | 2/28 (7.1%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Back Pain | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 3/51 (5.9%) | |||||||
| Nervous system disorders | ||||||||||||||
| Neuropathy Peripheral | 2/28 (7.1%) | 0/53 (0%) | 3/33 (9.1%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Dementia | 2/28 (7.1%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Headache | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Restless Legs Syndrome | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Depression | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 3/42 (7.1%) | 0/6 (0%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Stress Urinary Incontinence | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Reproductive system and breast disorders | ||||||||||||||
| Benign Prostatic Hyperplasia | 0/9 (0%) | 0/29 (0%) | 0/16 (0%) | 3/22 (13.6%) | 0/3 (0%) | 0/0 (NaN) | 0/30 (0%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Alopecia | 0/28 (0%) | 0/53 (0%) | 0/33 (0%) | 0/42 (0%) | 1/6 (16.7%) | 0/2 (0%) | 0/51 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Hypertension | 0/28 (0%) | 3/53 (5.7%) | 3/33 (9.1%) | 4/42 (9.5%) | 0/6 (0%) | 0/2 (0%) | 4/51 (7.8%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Therapeutic Area Head, |
|---|---|
| Organization | Allergan, Inc |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01080209
Other Study ID Numbers:
- 190342-033D
First Posted:
Mar 4, 2010
Last Update Posted:
Feb 20, 2015
Last Verified:
Feb 1, 2015