Primary Open-Angle Glaucoma, Ocular Hypertension
Conditions
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).
Interventions
DRUGBimatoprost
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.
Sponsors
ForSight Vision5, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Completed FSV5-004 study. 2. Written informed consent prior to any study procedure. 3. Willingness to comply with the visit schedule. Key
Exclusion criteria
1. Participation in an investigational drug or device study other than FSV5-004 within the past 6 months or anticipated participation during the study period. 2. Subjects who will require contact lens use during the study period. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants who completed the Phase 2 study FSV5-004 \[NCT02358369\] were eligible to enroll in this open-label extension study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Other Miscellaneous Reasons | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | 13 mg Bimatoprost Ocular Insert |
|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 9.89 |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 81 |
| serious Total, serious adverse events | 7 / 81 |
Outcome results
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.
Time frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
Population: Safety Population included all enrolled participants who had at least one 13 mg Bimatoprost Ocular Insert placed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Ocular, Mild | 25.9 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Ocular, Moderate | 11.1 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Non-Ocular, Mild | 6.2 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Ocular, Severe | 0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Non-Ocular, Moderate | 8.6 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Non-Ocular, Severe | 4.9 percentage of 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.
Time frame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)
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.
Time frame: Baseline (Day 0, enrollment in this study) to end of study (Week 38)
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.
Time frame: Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38
Population: Per Protocol, this Outcome Measure previously registered on ClinicalTrials.gov as a Secondary Outcome Measure is an Other Pre-specified Outcome Measure.
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.
Time frame: Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38
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.
Time frame: Baseline (Day 0, enrollment in this study) to the end of study (Week 38)