Primary Open-Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
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.
Interventions
DRUGBimatoprost
Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.
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 FSV5-002 study. 2. Written informed consent prior to any study procedure. 3. Willingness to comply with the visit schedule.
Exclusion criteria
1. Participation in an investigational drug or device study other than FSV5-002 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 | 13 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure (IOP) | Baseline (Day 1) to Month 13 | 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 \[NCT01915940\]. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | 13 mg Bimatoprost Ocular Insert |
|---|---|
| Age, Continuous | 65.27 years STANDARD_DEVIATION 9.21 |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 75 |
| serious Total, serious adverse events | 1 / 75 |
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: 13 months
Population: Safety population included all randomized participants who had ocular inserts placed in their eyes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Non-ocular, Severe | 1.3 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Ocular, Mild | 53.3 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Ocular, Moderate | 14.7 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Ocular, Severe | 1.3 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Non-ocular, Mild | 12.0 percentage of participants |
| 13 mg Bimatoprost Ocular Insert | Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity | Non-ocular, Moderate | 18.7 percentage of participants |
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 \[NCT01915940\].
Time frame: Baseline (Day 1) to Month 13
Population: 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,
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 13 mg Bimatoprost Ocular Insert | Change From Baseline in Mean Intraocular Pressure (IOP) | -4 mm Hg |