OLE2: An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Drug: Bimatoprost
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity [Baseline (Day 0, enrollment in this study) to end of study (Week 38)]
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.
Other Outcome Measures
- Change From Baseline in Intraocular Pressure (IOP) [Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38]
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.
- Percentage of Participants by Subject-Reported Comfort Assessment Categories [Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38]
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.
- Bimatoprost Ocular Insert Retention Duration [Baseline (Day 0, enrollment in this study) to the end of study (Week 38)]
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.
- Percentage of Participants Who Received Rescue Treatment [Baseline (Day 0, enrollment in this study) to the end of study (Week 38)]
Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.
- Change From Baseline in Endothelial Cell Count [Baseline (Day 0, enrollment in this study) to end of study (Week 38)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Completed FSV5-004 study.
-
Written informed consent prior to any study procedure.
-
Willingness to comply with the visit schedule.
Key Exclusion Criteria:
-
Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period.
-
Subjects who will require contact lens use during the study period.
-
Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Vold Vision | Fayetteville | Arkansas | United States | 72704 |
2 | Sall Medical Research Center | Artesia | California | United States | 90701 |
3 | Eye Research Foundation | Newport Beach | California | United States | 92663 |
4 | Clayton Eye Center | Morrow | Georgia | United States | 30260 |
5 | Mundorf Eye Center | Charlotte | North Carolina | United States | 28204 |
6 | Cornerstone Health Care; Cornerstone Eye Care | High Point | North Carolina | United States | 27262 |
7 | University Eye Specialists | Maryville | Tennessee | United States | 37803 |
8 | Total Eye Care | Memphis | Tennessee | United States | 38119 |
9 | R&R Eye Research, LLC | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- ForSight Vision5, Inc.
Investigators
- Study Director: Michelle Chen, PhD, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FSV5-005 OLE 2
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | Participants who completed the Phase 2 study FSV5-004 [NCT02358369] were eligible to enroll in this open-label extension study. |
Arm/Group Title | 13 mg Bimatoprost Ocular Insert |
---|---|
Arm/Group Description | 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. |
Period Title: Overall Study | |
STARTED | 81 |
COMPLETED | 75 |
NOT COMPLETED | 6 |
Baseline Characteristics
Arm/Group Title | 13 mg Bimatoprost Ocular Insert |
---|---|
Arm/Group Description | 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. |
Overall Participants | 81 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
64.8
(9.89)
|
Sex: Female, Male (Count of Participants) | |
Female |
52
64.2%
|
Male |
29
35.8%
|
Outcome Measures
Title | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity |
---|---|
Description | 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. |
Time Frame | Baseline (Day 0, enrollment in this study) to end of study (Week 38) |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population included all enrolled participants who had at least one 13 mg Bimatoprost Ocular Insert placed. |
Arm/Group Title | 13 mg Bimatoprost Ocular Insert |
---|---|
Arm/Group Description | 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. |
Measure Participants | 81 |
Ocular, Mild |
25.9
32%
|
Ocular, Moderate |
11.1
13.7%
|
Ocular, Severe |
0
0%
|
Non-Ocular, Mild |
6.2
7.7%
|
Non-Ocular, Moderate |
8.6
10.6%
|
Non-Ocular, Severe |
4.9
6%
|
Title | Change From Baseline in Intraocular Pressure (IOP) |
---|---|
Description | 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. |
Time Frame | Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Percentage of Participants by Subject-Reported Comfort Assessment Categories |
---|---|
Description | 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. |
Time Frame | Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Bimatoprost Ocular Insert Retention Duration |
---|---|
Description | 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. |
Time Frame | Baseline (Day 0, enrollment in this study) to the end of study (Week 38) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Percentage of Participants Who Received Rescue Treatment |
---|---|
Description | Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP. |
Time Frame | Baseline (Day 0, enrollment in this study) to the end of study (Week 38) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Change From Baseline in Endothelial Cell Count |
---|---|
Description | 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. |
Time Frame | Baseline (Day 0, enrollment in this study) to end of study (Week 38) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | Baseline (Day 0-enrollment in this study) to the end of study (Week 38) | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | 13 mg Bimatoprost Ocular Insert | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
13 mg Bimatoprost Ocular Insert | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
13 mg Bimatoprost Ocular Insert | ||
Affected / at Risk (%) | # Events | |
Total | 7/81 (8.6%) | |
Cardiac disorders | ||
Atrial fibrillation | 1/81 (1.2%) | |
Hepatobiliary disorders | ||
Cholelithiasis | 1/81 (1.2%) | |
Injury, poisoning and procedural complications | ||
Hip fracture | 1/81 (1.2%) | |
Upper limb fracture | 1/81 (1.2%) | |
Metabolism and nutrition disorders | ||
Fluid overload | 1/81 (1.2%) | |
Respiratory, thoracic and mediastinal disorders | ||
Chronic obstructive pulmonary disease | 1/81 (1.2%) | |
Vascular disorders | ||
Hypertension | 1/81 (1.2%) | |
Other (Not Including Serious) Adverse Events |
||
13 mg Bimatoprost Ocular Insert | ||
Affected / at Risk (%) | # Events | |
Total | 20/81 (24.7%) | |
Eye disorders | ||
Punctate keratitis | 10/81 (12.3%) | |
Eye discharge | 9/81 (11.1%) | |
Ocular discomfort | 5/81 (6.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Therapeutic Area Head, |
---|---|
Organization | Allergan, Inc |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- FSV5-005 OLE 2