Trial Outcomes & Findings for Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension (NCT NCT02558374)
NCT ID: NCT02558374
Last Updated: 2018-04-06
Results Overview
The primary efficacy outcome is mean IOP
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
708 participants
Primary outcome timeframe
3 months
Results posted on
2018-04-06
Participant Flow
Participants were recruited at 53 sites starting in September 2015
Participant milestones
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|
|
Overall Study
STARTED
|
351
|
357
|
|
Overall Study
COMPLETED
|
243
|
314
|
|
Overall Study
NOT COMPLETED
|
108
|
43
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=351 Participants
1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=357 Participants
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
Total
n=708 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 11.55 • n=93 Participants
|
64.5 years
STANDARD_DEVIATION 10.97 • n=4 Participants
|
64.3 years
STANDARD_DEVIATION 11.25 • n=27 Participants
|
|
Sex: Female, Male
Female
|
208 Participants
n=93 Participants
|
237 Participants
n=4 Participants
|
445 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
263 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
89 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
176 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
262 Participants
n=93 Participants
|
270 Participants
n=4 Participants
|
532 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
259 Participants
n=93 Participants
|
274 Participants
n=4 Participants
|
533 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Per-Protocol Population
The primary efficacy outcome is mean IOP
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=306 Participants
1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=316 Participants
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|
|
IOP (Intraocular Pressure)
Day 1, 0800 hours
|
23.93 mmHg
Standard Deviation 2.441
|
23.89 mmHg
Standard Deviation 2.318
|
|
IOP (Intraocular Pressure)
Day 1, 1000 hours
|
22.67 mmHg
Standard Deviation 2.826
|
22.77 mmHg
Standard Deviation 2.565
|
|
IOP (Intraocular Pressure)
Day 1, 1600 hours
|
22.17 mmHg
Standard Deviation 2.857
|
22.04 mmHg
Standard Deviation 2.708
|
|
IOP (Intraocular Pressure)
Day 15, 0800 hours
|
19.20 mmHg
Standard Deviation 3.833
|
18.60 mmHg
Standard Deviation 3.396
|
|
IOP (Intraocular Pressure)
Day 15, 1000 hours
|
17.93 mmHg
Standard Deviation 3.678
|
17.80 mmHg
Standard Deviation 3.237
|
|
IOP (Intraocular Pressure)
Day 15, 1600 hours
|
17.76 mmHg
Standard Deviation 3.527
|
17.85 mmHg
Standard Deviation 3.102
|
|
IOP (Intraocular Pressure)
Day 43, 0800 hours
|
19.45 mmHg
Standard Deviation 3.929
|
18.52 mmHg
Standard Deviation 3.316
|
|
IOP (Intraocular Pressure)
Day 43, 1000 hours
|
18.12 mmHg
Standard Deviation 3.560
|
17.89 mmHg
Standard Deviation 3.157
|
|
IOP (Intraocular Pressure)
Day 43, 1600 hours
|
17.89 mmHg
Standard Deviation 3.438
|
17.88 mmHg
Standard Deviation 3.356
|
|
IOP (Intraocular Pressure)
Day 90, 0800 hours
|
19.24 mmHg
Standard Deviation 3.889
|
18.35 mmHg
Standard Deviation 3.196
|
|
IOP (Intraocular Pressure)
Day 90, 1000 hours
|
18.30 mmHg
Standard Deviation 3.637
|
17.60 mmHg
Standard Deviation 3.173
|
|
IOP (Intraocular Pressure)
Day 90, 1600 hours
|
18.02 mmHg
Standard Deviation 3.644
|
17.66 mmHg
Standard Deviation 3.080
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Safety Population
Exposure to study medication in days for all treatment groups
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=351 Participants
1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=357 Participants
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|
|
Extent of Exposure
|
147.4 days
Standard Deviation 54.47
|
167.7 days
Standard Deviation 36.40
|
Adverse Events
AR-13324 Ophthalmic Solution 0.02% & Placebo
Serious events: 8 serious events
Other events: 245 other events
Deaths: 1 deaths
Timolol Maleate Ophthalmic Solution 0.5% BID
Serious events: 10 serious events
Other events: 139 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=351 participants at risk
1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=357 participants at risk
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Recurrent
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Myeloid Leukaemia
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.28%
1/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Gastrointestinal disorders
Gastric Volvulus
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/351 • 6 months
|
0.28%
1/357 • 6 months
|
|
Renal and urinary disorders
Bladder Prolapse
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.28%
1/351 • 6 months
|
0.00%
0/357 • 6 months
|
Other adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=351 participants at risk
1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=357 participants at risk
1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
47.9%
168/351 • 6 months
|
9.2%
33/357 • 6 months
|
|
Eye disorders
Cornea Verticillata
|
24.5%
86/351 • 6 months
|
0.00%
0/357 • 6 months
|
|
Eye disorders
Conjunctival Haemorrhage
|
16.0%
56/351 • 6 months
|
3.1%
11/357 • 6 months
|
|
Eye disorders
Lacrimation Increased
|
7.4%
26/351 • 6 months
|
1.4%
5/357 • 6 months
|
|
Eye disorders
Erythema of Eyelid
|
7.4%
26/351 • 6 months
|
0.56%
2/357 • 6 months
|
|
Eye disorders
Vision Blurred
|
6.3%
22/351 • 6 months
|
1.1%
4/357 • 6 months
|
|
General disorders
Instillation Site Pain
|
23.6%
83/351 • 6 months
|
25.8%
92/357 • 6 months
|
|
General disorders
Instillation Site Erythema
|
10.3%
36/351 • 6 months
|
1.1%
4/357 • 6 months
|
|
Investigations
Vital Dye Staining Cornea Present
|
9.7%
34/351 • 6 months
|
6.7%
24/357 • 6 months
|
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