Open-Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension
Interventions
DRUGBimatoprost SR
Consists of 1 Bimatoprost SR administration in the study eye.
DRUGLUMIGAN
Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment * Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months
Exclusion criteria
* Current or anticipated enrollment in another investigational drug or device study * Females who are pregnant, nursing, or planning a pregnancy during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | 8 weeks | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. |
| Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | Up to 12 Months | The number of patients who experienced one or more TEAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes | 8 Weeks | IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost SR 10 μg Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
Bimatoprost SR: Consists of 1 Bimatoprost SR administration in the study eye. | 31 |
| LUMIGAN 0.01% Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
LUMIGAN: Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study. | 6 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | LUMIGAN 0.01% | Total | Bimatoprost SR 10 μg |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 25 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 12 Participants | 10 Participants |
| Age, Continuous | 70.2 years STANDARD_DEVIATION 8.52 | 70.4 years STANDARD_DEVIATION 11.24 | 70.5 years STANDARD_DEVIATION 11.81 |
| Baseline Hour 0 Intraocular Pressure (IOP) <= 25 mmHg | 3 Participants | 29 Participants | 26 Participants |
| Baseline Hour 0 Intraocular Pressure (IOP) > 25 mmHg | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 34 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 8 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 26 Participants | 22 Participants |
| Sex: Female, Male Female | 2 Participants | 20 Participants | 18 Participants |
| Sex: Female, Male Male | 4 Participants | 17 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 6 |
| other Total, other adverse events | 20 / 31 | 5 / 6 |
| serious Total, serious adverse events | 1 / 31 | 0 / 6 |
Outcome results
Primary
Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time frame: 8 weeks
Population: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 08:00 | -3.7 Millimeters of Mercury (mmHg) | Standard Deviation 5.65 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 10:00 | -2.5 Millimeters of Mercury (mmHg) | Standard Deviation 4.46 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 12:00 | -2.9 Millimeters of Mercury (mmHg) | Standard Deviation 3.36 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 14:00 | -1.8 Millimeters of Mercury (mmHg) | Standard Deviation 4.31 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 16:00 | -3.3 Millimeters of Mercury (mmHg) | Standard Deviation 3.8 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 18:00 | -1.9 Millimeters of Mercury (mmHg) | Standard Deviation 4.59 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 20:00 | -2.6 Millimeters of Mercury (mmHg) | Standard Deviation 4.29 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 22:00 | -2.3 Millimeters of Mercury (mmHg) | Standard Deviation 3.66 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 00:00 | -1.7 Millimeters of Mercury (mmHg) | Standard Deviation 3.6 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 02:00 | -2.4 Millimeters of Mercury (mmHg) | Standard Deviation 4.04 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 04:00 | -2.1 Millimeters of Mercury (mmHg) | Standard Deviation 3.85 |
| Bimatoprost SR 10 μg | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 06:00 | -2.2 Millimeters of Mercury (mmHg) | Standard Deviation 4.42 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 04:00 | -3.2 Millimeters of Mercury (mmHg) | Standard Deviation 1.3 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 08:00 | -4.0 Millimeters of Mercury (mmHg) | Standard Deviation 5.27 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 20:00 | -5.0 Millimeters of Mercury (mmHg) | Standard Deviation 2.03 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 10:00 | -3.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.09 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 02:00 | -3.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.25 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 12:00 | -5.0 Millimeters of Mercury (mmHg) | Standard Deviation 2.72 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 22:00 | -2.1 Millimeters of Mercury (mmHg) | Standard Deviation 2.48 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 14:00 | -4.4 Millimeters of Mercury (mmHg) | Standard Deviation 2.04 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 06:00 | -5.0 Millimeters of Mercury (mmHg) | Standard Deviation 3.34 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 16:00 | -4.2 Millimeters of Mercury (mmHg) | Standard Deviation 3.01 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Nocturnal/Sleep Period Hour 00:00 | -1.8 Millimeters of Mercury (mmHg) | Standard Deviation 4.28 |
| LUMIGAN 0.01% | Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes | Diurnal/Wake Period Hour 18:00 | -4.2 Millimeters of Mercury (mmHg) | Standard Deviation 2.08 |
Primary
Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
The number of patients who experienced one or more TEAEs
Time frame: Up to 12 Months
Population: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bimatoprost SR 10 μg | Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | 12 Participants |
| LUMIGAN 0.01% | Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | 4 Participants |
Secondary
Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP.
Time frame: 8 Weeks
Population: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bimatoprost SR 10 μg | Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes | -1.6 Millimeters of Mercury (mmHg) | Standard Deviation 2.98 |
| LUMIGAN 0.01% | Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes | 0.7 Millimeters of Mercury (mmHg) | Standard Deviation 3.9 |