Trial Outcomes & Findings for Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure (NCT NCT01731002)
NCT ID: NCT01731002
Last Updated: 2018-04-17
Results Overview
The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
224 participants
Primary outcome timeframe
Study treatment was administered for 28 days
Results posted on
2018-04-17
Participant Flow
Participant milestones
| Measure |
AR-13324 Ophthalmic Solution 0.01%
1 drop to study eye once daily (QD) in the evening (PM)
|
AR-13324 Ophthalmic Solution 0.02%
1 drop to study eye once daily (QD) in the evening (PM)
|
Latanoprost Ophthalmic Solution 0.005%
1 drop to study eye once daily (QD) in the evening (PM)
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
72
|
77
|
|
Overall Study
COMPLETED
|
71
|
68
|
74
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
Reasons for withdrawal
| Measure |
AR-13324 Ophthalmic Solution 0.01%
1 drop to study eye once daily (QD) in the evening (PM)
|
AR-13324 Ophthalmic Solution 0.02%
1 drop to study eye once daily (QD) in the evening (PM)
|
Latanoprost Ophthalmic Solution 0.005%
1 drop to study eye once daily (QD) in the evening (PM)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
|
Overall Study
Non-Compliant
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Test Agent Discontinuation
|
0
|
1
|
0
|
|
Overall Study
Uncontrolled Intraocular Pressure (IOP)
|
2
|
0
|
0
|
|
Overall Study
Elevated IOP
|
1
|
0
|
0
|
|
Overall Study
Inappropriate use of study medications
|
0
|
0
|
1
|
Baseline Characteristics
Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
Baseline characteristics by cohort
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=75 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
AR-13324 Ophthalmic Solution 0.02%
n=72 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
Latanoprost Ophthalmic Solution 0.005%
n=77 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 11.54 • n=93 Participants
|
66.3 years
STANDARD_DEVIATION 10.25 • n=4 Participants
|
65.7 years
STANDARD_DEVIATION 11.82 • n=27 Participants
|
65.1 years
STANDARD_DEVIATION 11.26 • n=483 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
132 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
92 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
178 Participants
n=483 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 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
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
167 Participants
n=483 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Study treatment was administered for 28 daysPopulation: Modified intent to treat (mITT) population (3 subjects were excluded, leaving 221)
The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=74 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
AR-13324 Ophthalmic Solution 0.02%
n=71 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
Latanoprost Ophthalmic Solution 0.005%
n=76 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
|---|---|---|---|
|
Intraocular Pressure (IOP)
Day 0, 0800 hours
|
27.34 mmHg
Standard Deviation 3.529
|
27.11 mmHg
Standard Deviation 3.031
|
26.78 mmHg
Standard Deviation 2.749
|
|
Intraocular Pressure (IOP)
Day 0, 1000 hours
|
25.55 mmHg
Standard Deviation 3.411
|
25.41 mmHg
Standard Deviation 3.024
|
25.18 mmHg
Standard Deviation 2.719
|
|
Intraocular Pressure (IOP)
Day 0, 1600 hours
|
24.49 mmHg
Standard Deviation 3.128
|
24.29 mmHg
Standard Deviation 2.602
|
24.58 mmHg
Standard Deviation 2.515
|
|
Intraocular Pressure (IOP)
Day 7, 0800 hours
|
21.89 mmHg
Standard Deviation 4.672
|
21.15 mmHg
Standard Deviation 4.047
|
20.03 mmHg
Standard Deviation 3.173
|
|
Intraocular Pressure (IOP)
Day 14, 0800 hours
|
21.24 mmHg
Standard Deviation 4.295
|
20.80 mmHg
Standard Deviation 3.679
|
19.30 mmHg
Standard Deviation 3.033
|
|
Intraocular Pressure (IOP)
Day 14, 1000 hours
|
19.28 mmHg
Standard Deviation 3.581
|
18.88 mmHg
Standard Deviation 3.461
|
18.09 mmHg
Standard Deviation 2.884
|
|
Intraocular Pressure (IOP)
Day 14, 1600 hours
|
18.90 mmHg
Standard Deviation 3.578
|
18.72 mmHg
Standard Deviation 3.585
|
17.86 mmHg
Standard Deviation 2.977
|
|
Intraocular Pressure (IOP)
Day 28, 0800 hours
|
21.95 mmHg
Standard Deviation 4.717
|
21.24 mmHg
Standard Deviation 4.034
|
19.24 mmHg
Standard Deviation 2.899
|
|
Intraocular Pressure (IOP)
Day 28, 1000 hours
|
19.69 mmHg
Standard Deviation 4.358
|
19.53 mmHg
Standard Deviation 3.726
|
18.40 mmHg
Standard Deviation 2.994
|
|
Intraocular Pressure (IOP)
Day 28, 1600 hours
|
18.82 mmHg
Standard Deviation 3.281
|
19.13 mmHg
Standard Deviation 3.656
|
18.34 mmHg
Standard Deviation 3.052
|
SECONDARY outcome
Timeframe: 28 DaysExposure to study medication in days for all treatment groups.
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=75 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
AR-13324 Ophthalmic Solution 0.02%
n=72 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
Latanoprost Ophthalmic Solution 0.005%
n=77 Participants
1 drop to study eye once daily (QD) in the evening (PM)
|
|---|---|---|---|
|
Extent of Exposure
|
27.6 days
Standard Deviation 4.07
|
26.8 days
Standard Deviation 4.6
|
27.8 days
Standard Deviation 1.35
|
Adverse Events
AR-13324 Ophthalmic Solution 0.01%
Serious events: 1 serious events
Other events: 43 other events
Deaths: 1 deaths
AR-13324 Ophthalmic Solution 0.02%
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Latanoprost Ophthalmic Solution 0.005%
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=75 participants at risk
1 drop to study eye once daily (QD) in the evening (PM)
|
AR-13324 Ophthalmic Solution 0.02%
n=72 participants at risk
1 drop to study eye once daily (QD) in the evening (PM)
|
Latanoprost Ophthalmic Solution 0.005%
n=77 participants at risk
1 drop to study eye once daily (QD) in the evening (PM)
|
|---|---|---|---|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/75 • 28 Days
|
0.00%
0/72 • 28 Days
|
1.3%
1/77 • 28 Days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/75 • 28 Days
|
0.00%
0/72 • 28 Days
|
1.3%
1/77 • 28 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Leukaemia
|
1.3%
1/75 • 28 Days
|
0.00%
0/72 • 28 Days
|
0.00%
0/77 • 28 Days
|
Other adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.01%
n=75 participants at risk
1 drop to study eye once daily (QD) in the evening (PM)
|
AR-13324 Ophthalmic Solution 0.02%
n=72 participants at risk
1 drop to study eye once daily (QD) in the evening (PM)
|
Latanoprost Ophthalmic Solution 0.005%
n=77 participants at risk
1 drop to study eye once daily (QD) in the evening (PM)
|
|---|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
38.7%
29/75 • 28 Days
|
47.2%
34/72 • 28 Days
|
15.6%
12/77 • 28 Days
|
|
Eye disorders
Ocular Hyperaemia
|
13.3%
10/75 • 28 Days
|
9.7%
7/72 • 28 Days
|
0.00%
0/77 • 28 Days
|
|
Eye disorders
Lacrimation Increased
|
5.3%
4/75 • 28 Days
|
6.9%
5/72 • 28 Days
|
0.00%
0/77 • 28 Days
|
|
Eye disorders
Conjunctival Haemorrhage
|
5.3%
4/75 • 28 Days
|
5.6%
4/72 • 28 Days
|
0.00%
0/77 • 28 Days
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
0.00%
0/75 • 28 Days
|
6.9%
5/72 • 28 Days
|
3.9%
3/77 • 28 Days
|
|
General disorders
Instillation Site Pain
|
6.7%
5/75 • 28 Days
|
12.5%
9/72 • 28 Days
|
5.2%
4/77 • 28 Days
|
Additional Information
Nancy Ramirez-Davis, Director of 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