Trial Outcomes & Findings for Study of AR-13324 in Patients With Elevated Intraocular Pressure (NCT NCT01528787)
NCT ID: NCT01528787
Last Updated: 2018-04-18
Results Overview
The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8. Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.
Results posted on
2018-04-18
Participant Flow
Participant milestones
| Measure |
AR-13324 Ophthalmic Solution 0.01%
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.02%
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.04%
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Opththalmic Solution Vehicle
1 drop to study eye once daily (QD) in the morning (AM)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
19
|
23
|
|
Overall Study
COMPLETED
|
22
|
21
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
AR-13324 Ophthalmic Solution 0.01%
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.02%
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.04%
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Opththalmic Solution Vehicle
1 drop to study eye once daily (QD) in the morning (AM)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Family Emergency
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of AR-13324 in Patients With Elevated Intraocular Pressure
Baseline characteristics by cohort
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=22 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.02%
n=21 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.04%
n=19 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution Vehicle
n=23 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 12.36 • n=93 Participants
|
69.1 years
STANDARD_DEVIATION 8.69 • n=4 Participants
|
66.1 years
STANDARD_DEVIATION 11.09 • n=27 Participants
|
57.8 years
STANDARD_DEVIATION 12.27 • n=483 Participants
|
64.0 years
STANDARD_DEVIATION 11.83 • n=36 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
51 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
74 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
74 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.Population: Modified intent to treat (mITT) population (85 patients receiving investigational treatment). Participants who did not complete the study did not contribute data at later time points.
The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8. Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=22 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.02%
n=21 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.04%
n=19 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution Vehicle
n=23 Participants
1 drop to study eye once daily (QD) in the morning (AM)
|
|---|---|---|---|---|
|
Intraocular Pressure (IOP)
Day 8, 1600 hours
|
17.68 mmHg
Standard Deviation 3.161
|
16.88 mmHg
Standard Deviation 3.049
|
17.83 mmHg
Standard Deviation 3.510
|
21.52 mmHg
Standard Deviation 4.244
|
|
Intraocular Pressure (IOP)
Day 2, 1200 hours
|
21.93 mmHg
Standard Deviation 2.997
|
21.95 mmHg
Standard Deviation 3.653
|
25.00 mmHg
Standard Deviation 5.292
|
22.91 mmHg
Standard Deviation 2.863
|
|
Intraocular Pressure (IOP)
Day 2, 1600 hours
|
20.70 mmHg
Standard Deviation 3.521
|
20.88 mmHg
Standard Deviation 3.467
|
22.29 mmHg
Standard Deviation 4.849
|
21.41 mmHg
Standard Deviation 3.110
|
|
Intraocular Pressure (IOP)
Day 4, 0800 hours
|
21.32 mmHg
Standard Deviation 4.049
|
21.00 mmHg
Standard Deviation 4.530
|
22.00 mmHg
Standard Deviation 5.352
|
23.98 mmHg
Standard Deviation 3.730
|
|
Intraocular Pressure (IOP)
Day 8, 0800 hours
|
20.82 mmHg
Standard Deviation 5.487
|
20.60 mmHg
Standard Deviation 3.491
|
20.44 mmHg
Standard Deviation 3.933
|
24.34 mmHg
Standard Deviation 3.663
|
|
Intraocular Pressure (IOP)
Day 8, 1000 hours
|
18.20 mmHg
Standard Deviation 4.165
|
18.71 mmHg
Standard Deviation 3.208
|
19.42 mmHg
Standard Deviation 3.663
|
22.34 mmHg
Standard Deviation 4.034
|
|
Intraocular Pressure (IOP)
Day 8, 1200 hours
|
17.57 mmHg
Standard Deviation 4.255
|
17.88 mmHg
Standard Deviation 3.457
|
18.78 mmHg
Standard Deviation 4.486
|
21.93 mmHg
Standard Deviation 3.818
|
|
Intraocular Pressure (IOP)
Day 2, 0800 hours
|
25.80 mmHg
Standard Deviation 3.699
|
26.02 mmHg
Standard Deviation 2.542
|
26.50 mmHg
Standard Deviation 3.358
|
25.17 mmHg
Standard Deviation 2.980
|
|
Intraocular Pressure (IOP)
Day 2, 1000 hours
|
22.45 mmHg
Standard Deviation 3.713
|
22.10 mmHg
Standard Deviation 3.149
|
24.29 mmHg
Standard Deviation 5.347
|
22.87 mmHg
Standard Deviation 2.681
|
Adverse Events
AR-13324 Ophthalmic Solution 0.01%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
AR-13324 Ophthalmic Solution 0.02%
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
AR-13324 Ophthalmic Solution 0.04%
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
AR-13324 Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=22 participants at risk
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.02%
n=21 participants at risk
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution 0.04%
n=19 participants at risk
1 drop to study eye once daily (QD) in the morning (AM)
|
AR-13324 Ophthalmic Solution Vehicle
n=23 participants at risk
1 drop to study eye once daily (QD) in the morning (AM)
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
50.0%
11/22
|
57.1%
12/21
|
73.7%
14/19
|
4.3%
1/23
|
|
Eye disorders
Ocular Hyperaemia
|
4.5%
1/22
|
4.8%
1/21
|
15.8%
3/19
|
0.00%
0/23
|
|
Eye disorders
Erythema of Eyelid
|
0.00%
0/22
|
4.8%
1/21
|
5.3%
1/19
|
0.00%
0/23
|
|
Eye disorders
Vision Blurred
|
0.00%
0/22
|
9.5%
2/21
|
5.3%
1/19
|
0.00%
0/23
|
|
Eye disorders
Diplopia
|
0.00%
0/22
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/23
|
|
Eye disorders
Dry Eye
|
0.00%
0/22
|
9.5%
2/21
|
0.00%
0/19
|
0.00%
0/23
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/22
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/23
|
|
General disorders
Instillation Site Reaction
|
0.00%
0/22
|
0.00%
0/21
|
10.5%
2/19
|
0.00%
0/23
|
|
Investigations
Corneal Staining
|
0.00%
0/22
|
9.5%
2/21
|
5.3%
1/19
|
0.00%
0/23
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/22
|
4.8%
1/21
|
5.3%
1/19
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/22
|
0.00%
0/21
|
5.3%
1/19
|
0.00%
0/23
|
Additional Information
Nancy Ramirez-Davis, Director Clinical Project Management
Aerie Pharmaceuticals, Inc.
Phone: 908-947-3543
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place