Trial Outcomes & Findings for A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT04285580)
NCT ID: NCT04285580
Last Updated: 2023-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
37 participants
Primary outcome timeframe
8 weeks
Results posted on
2023-06-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
6
|
|
Overall Study
COMPLETED
|
31
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Bimatoprost SR 10 μg
n=31 Participants
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.
|
LUMIGAN 0.01%
n=6 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 8.52 • n=7 Participants
|
70.4 years
STANDARD_DEVIATION 11.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Hour 0 Intraocular Pressure (IOP)
<= 25 mmHg
|
26 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Baseline Hour 0 Intraocular Pressure (IOP)
> 25 mmHg
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment.
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.
Outcome measures
| Measure |
Bimatoprost SR 10 μg
n=31 Participants
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.
|
LUMIGAN 0.01%
n=5 Participants
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.
|
|---|---|---|
|
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
|
-4.0 Millimeters of Mercury (mmHg)
Standard Deviation 5.27
|
|
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
|
-3.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.09
|
|
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
|
-5.0 Millimeters of Mercury (mmHg)
Standard Deviation 2.72
|
|
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
|
-4.4 Millimeters of Mercury (mmHg)
Standard Deviation 2.04
|
|
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 3.80
|
-4.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.01
|
|
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
|
-4.2 Millimeters of Mercury (mmHg)
Standard Deviation 2.08
|
|
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
|
-5.0 Millimeters of Mercury (mmHg)
Standard Deviation 2.03
|
|
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
|
-2.1 Millimeters of Mercury (mmHg)
Standard Deviation 2.48
|
|
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 3.60
|
-1.8 Millimeters of Mercury (mmHg)
Standard Deviation 4.28
|
|
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
|
-3.2 Millimeters of Mercury (mmHg)
Standard Deviation 3.25
|
|
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
|
-3.2 Millimeters of Mercury (mmHg)
Standard Deviation 1.30
|
|
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
|
-5.0 Millimeters of Mercury (mmHg)
Standard Deviation 3.34
|
PRIMARY outcome
Timeframe: Up to 12 MonthsPopulation: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%)
The number of patients who experienced one or more TEAEs
Outcome measures
| Measure |
Bimatoprost SR 10 μg
n=31 Participants
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.
|
LUMIGAN 0.01%
n=6 Participants
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.
|
|---|---|---|
|
Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: All participants who have received study intervention (ie, Bimatoprost SR administration or LUMIGAN 0.01%) with at least 1 postbaseline IOP assessment.
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.
Outcome measures
| Measure |
Bimatoprost SR 10 μg
n=31 Participants
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.
|
LUMIGAN 0.01%
n=5 Participants
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.
|
|---|---|---|
|
Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes
|
-1.6 Millimeters of Mercury (mmHg)
Standard Deviation 2.98
|
0.7 Millimeters of Mercury (mmHg)
Standard Deviation 3.90
|
Adverse Events
Bimatoprost SR 10 μg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
LUMIGAN 0.01%
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost SR 10 μg
n=31 participants at risk
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.
|
LUMIGAN 0.01%
n=6 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
3.2%
1/31 • Number of events 1 • 12 Months
|
0.00%
0/6 • 12 Months
|
Other adverse events
| Measure |
Bimatoprost SR 10 μg
n=31 participants at risk
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.
|
LUMIGAN 0.01%
n=6 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/31 • 12 Months
|
16.7%
1/6 • Number of events 1 • 12 Months
|
|
Eye disorders
CATARACT
|
6.5%
2/31 • Number of events 3 • 12 Months
|
0.00%
0/6 • 12 Months
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
9.7%
3/31 • Number of events 3 • 12 Months
|
0.00%
0/6 • 12 Months
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
35.5%
11/31 • Number of events 18 • 12 Months
|
66.7%
4/6 • Number of events 8 • 12 Months
|
|
Eye disorders
DRY EYE
|
6.5%
2/31 • Number of events 3 • 12 Months
|
0.00%
0/6 • 12 Months
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES
|
6.5%
2/31 • Number of events 2 • 12 Months
|
0.00%
0/6 • 12 Months
|
|
Eye disorders
PUNCTATE KERATITIS
|
6.5%
2/31 • Number of events 6 • 12 Months
|
0.00%
0/6 • 12 Months
|
|
Eye disorders
VISUAL FIELD DEFECT
|
9.7%
3/31 • Number of events 4 • 12 Months
|
0.00%
0/6 • 12 Months
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
22.6%
7/31 • Number of events 11 • 12 Months
|
0.00%
0/6 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER