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This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Experimental | 13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost | Drug | Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks. |
| 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. | Baseline (Day 0, enrollment in this study) to end of study (Week 38) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38. Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004. |
Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Chen, PhD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vold Vision | Fayetteville | Arkansas | 72704 | United States | ||
| Sall Medical Research Center |
Participants who completed the Phase 2 study FSV5-004 [NCT02358369] were eligible to enroll in this open-label extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13 mg Bimatoprost Ocular Insert | 13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38 |
| Percentage of Participants by Subject-Reported Comfort Assessment Categories | The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort. The percentage of participants in each rating category is reported. | Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38 |
| Bimatoprost Ocular Insert Retention Duration | Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1. | Baseline (Day 0, enrollment in this study) to the end of study (Week 38) |
| Percentage of Participants Who Received Rescue Treatment | Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP. | Baseline (Day 0, enrollment in this study) to the end of study (Week 38) |
| Change From Baseline in Endothelial Cell Count | Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38. | Baseline (Day 0, enrollment in this study) to end of study (Week 38) |
| Artesia |
| California |
| 90701 |
| United States |
| Eye Research Foundation | Newport Beach | California | 92663 | United States |
| Clayton Eye Center | Morrow | Georgia | 30260 | United States |
| Mundorf Eye Center | Charlotte | North Carolina | 28204 | United States |
| Cornerstone Health Care; Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| University Eye Specialists | Maryville | Tennessee | 37803 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| R&R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The safety population included all enrolled participants who had at least one Bimatoprost Ocular Insert 13 mg placed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 13 mg Bimatoprost Ocular Insert | 13 mg Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 enrolled participants who had at least one 13 mg Bimatoprost Ocular Insert placed. | Posted | Number | percentage of participants | Baseline (Day 0, enrollment in this study) to end of study (Week 38) |
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| Other Pre-specified | Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38. Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004. | Per Protocol, this Outcome Measure previously registered on ClinicalTrials.gov as a Secondary Outcome Measure is an Other Pre-specified Outcome Measure. | Not Posted | Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38 | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants by Subject-Reported Comfort Assessment Categories | The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort. The percentage of participants in each rating category is reported. | Not Posted | Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38 | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Bimatoprost Ocular Insert Retention Duration | Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1. | Not Posted | Baseline (Day 0, enrollment in this study) to the end of study (Week 38) | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Who Received Rescue Treatment | Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP. | Not Posted | Baseline (Day 0, enrollment in this study) to the end of study (Week 38) | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Endothelial Cell Count | Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38. | Not Posted | Baseline (Day 0, enrollment in this study) to end of study (Week 38) | Participants |
Baseline (Day 0-enrollment in this study) to the end of study (Week 38)
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| 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 in each eye used continuously for 12 weeks, then replaced with a new 13 mg Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks. | 7 | 81 | 20 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate keratitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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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 |
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| 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 |
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| Title | Measurements |
|---|---|
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| Non-Ocular, Mild |
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| Non-Ocular, Moderate |
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| Non-Ocular, Severe |
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