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 evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Experimental | 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost | Drug | Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (Time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Months 3, 6, 7 and 13. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal time-point, then averaged over 0, 2, and 8 hour to get the mean IOP. The change from baseline in mean IOP was calculated. The median value over the 13 month period is reported. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the last visit (Month 6) of study FSV5-002 [NCT01915940]. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michelle Chen, PhD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Medical Research Center | Artesia | California | 90701 | United States | ||
| Scripps Clinic Torrey Pines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28528010 | Derived | Brandt JD, DuBiner HB, Benza R, Sall KN, Walker GA, Semba CP; Collaborators. Long-term Safety and Efficacy of a Sustained-Release Bimatoprost Ocular Ring. Ophthalmology. 2017 Oct;124(10):1565-1566. doi: 10.1016/j.ophtha.2017.04.022. Epub 2017 May 17. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 13 mg Bimatoprost Ocular Insert | 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline (Day 1) to Month 13 |
| La Jolla |
| California |
| 92037 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| UC Davis Dept of Ophthalmology & Vision Science | Sacramento | California | 95817 | United States |
| Coastal Research Associates | Atlanta | Georgia | 30076 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Ophthalmology Consultants | St Louis | Missouri | 63131 | United States |
| UNC Kittner Eye Center | Chapel Hill | North Carolina | 27517 | United States |
| Apex Eye | Madeira | Ohio | 45243 | United States |
| Ophthalmology Associates PC | Fort Worth | Texas | 76102 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 13 mg Bimatoprost Ocular Insert | 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| 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 | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity. | Safety population included all randomized participants who had ocular inserts placed in their eyes. | Posted | Number | percentage of participants | 13 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (Time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Months 3, 6, 7 and 13. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal time-point, then averaged over 0, 2, and 8 hour to get the mean IOP. The change from baseline in mean IOP was calculated. The median value over the 13 month period is reported. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the last visit (Month 6) of study FSV5-002 [NCT01915940]. | Full Analysis Set (FAS) included all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, | Posted | Median | Inter-Quartile Range | mm Hg | Baseline (Day 1) to Month 13 |
|
|
Start of this Open-Label Extension Study to Last Visit (Up to 13 Months)
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 | 13 mg Bimatoprost Ocular Insert | 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months. | 1 | 75 | 42 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Non-ocular, Mild |
|
| Non-ocular, Moderate |
|
| Non-ocular, Severe |
|
|