Trial Outcomes & Findings for Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension (NCT NCT02246764)
NCT ID: NCT02246764
Last Updated: 2018-04-06
Results Overview
Exposure to study medication in days for all treatment groups
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
93 participants
Primary outcome timeframe
12 months
Results posted on
2018-04-06
Participant Flow
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)
|
AR-13324 Ophthalmic Solution 0.02% BID
1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
36
|
23
|
|
Overall Study
COMPLETED
|
16
|
4
|
19
|
|
Overall Study
NOT COMPLETED
|
18
|
32
|
4
|
Reasons for withdrawal
| 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)
|
AR-13324 Ophthalmic Solution 0.02% BID
1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
15
|
29
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Disallowed Concomitant Medication
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
Baseline Characteristics
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=34 Participants
1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
|
AR-13324 Ophthalmic Solution 0.02% BID
n=36 Participants
1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=23 Participants
1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 7.73 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 7.84 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 12.52 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 9.14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=5 Participants
|
36 participants
n=7 Participants
|
23 participants
n=5 Participants
|
93 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Safety Population
Exposure to study medication in days for all treatment groups
Outcome measures
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=34 Participants
1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)
|
AR-13324 Ophthalmic Solution 0.02% BID
n=36 Participants
1 drop AR-13324 twice daily (BID) in the morning and evening (PM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=23 Participants
1 drop Timolol maleate twice daily (BID) in the morning and evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Extent of Exposure
|
224.4 days
Standard Deviation 137.28
|
101.8 days
Standard Deviation 105.69
|
314.6 days
Standard Deviation 111.30
|
Adverse Events
AR-13324 Ophthalmic Solution 0.02% & Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
AR-13324 Ophthalmic Solution 0.02% BID
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Timolol Maleate Ophthalmic Solution 0.5% BID
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=34 participants at risk
1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
|
AR-13324 Ophthalmic Solution 0.02% BID
n=36 participants at risk
1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=23 participants at risk
1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
4.3%
1/23 • 1 year (12 months)
|
|
Eye disorders
Anterior Uveitis
|
0.00%
0/34 • 1 year (12 months)
|
2.8%
1/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
Other adverse events
| Measure |
AR-13324 Ophthalmic Solution 0.02% & Placebo
n=34 participants at risk
1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU)
|
AR-13324 Ophthalmic Solution 0.02% BID
n=36 participants at risk
1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
Timolol Maleate Ophthalmic Solution 0.5% BID
n=23 participants at risk
1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
|
|---|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
82.4%
28/34 • 1 year (12 months)
|
94.4%
34/36 • 1 year (12 months)
|
8.7%
2/23 • 1 year (12 months)
|
|
Eye disorders
Corneal Verticillata
|
38.2%
13/34 • 1 year (12 months)
|
38.9%
14/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Erythema of Eyelid
|
14.7%
5/34 • 1 year (12 months)
|
27.8%
10/36 • 1 year (12 months)
|
8.7%
2/23 • 1 year (12 months)
|
|
Eye disorders
Conjunctival Haemorrhage
|
20.6%
7/34 • 1 year (12 months)
|
16.7%
6/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Eyelid Oedema
|
11.8%
4/34 • 1 year (12 months)
|
19.4%
7/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Lacrimation Increased
|
20.6%
7/34 • 1 year (12 months)
|
11.1%
4/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Corneal Opacity
|
14.7%
5/34 • 1 year (12 months)
|
11.1%
4/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Blepharitis
|
5.9%
2/34 • 1 year (12 months)
|
13.9%
5/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Vision Blurred
|
5.9%
2/34 • 1 year (12 months)
|
13.9%
5/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Conjunctival Oedema
|
8.8%
3/34 • 1 year (12 months)
|
8.3%
3/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Eye Pruritis
|
8.8%
3/34 • 1 year (12 months)
|
8.3%
3/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Eye Pain
|
5.9%
2/34 • 1 year (12 months)
|
8.3%
3/36 • 1 year (12 months)
|
4.3%
1/23 • 1 year (12 months)
|
|
Eye disorders
Eye Irritation
|
2.9%
1/34 • 1 year (12 months)
|
8.3%
3/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Eyelids Pruritus
|
2.9%
1/34 • 1 year (12 months)
|
8.3%
3/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Foreign Body Sensation in Eye
|
0.00%
0/34 • 1 year (12 months)
|
11.1%
4/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Lenticular Opacities
|
8.8%
3/34 • 1 year (12 months)
|
2.8%
1/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Conjunctivochalasis
|
5.9%
2/34 • 1 year (12 months)
|
2.8%
1/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Eye Discharge
|
5.9%
2/34 • 1 year (12 months)
|
2.8%
1/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Photophobia
|
5.9%
2/34 • 1 year (12 months)
|
2.8%
1/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Eye Allergy
|
5.9%
2/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Eyelid Pain
|
0.00%
0/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Eye disorders
Optic Disc Haemorrhage
|
0.00%
0/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
4.3%
1/23 • 1 year (12 months)
|
|
Eye disorders
Dry Eye
|
2.9%
1/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
8.7%
2/23 • 1 year (12 months)
|
|
General disorders
Instillation Site Pain
|
26.5%
9/34 • 1 year (12 months)
|
22.2%
8/36 • 1 year (12 months)
|
26.1%
6/23 • 1 year (12 months)
|
|
General disorders
Instillation Site Discomfort
|
17.6%
6/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
4.3%
1/23 • 1 year (12 months)
|
|
General disorders
Instillation Site Erythema
|
5.9%
2/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
General disorders
Instillation Site Pruritus
|
5.9%
2/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Investigations
Vital Dye Staining Cornea Present
|
41.2%
14/34 • 1 year (12 months)
|
22.2%
8/36 • 1 year (12 months)
|
30.4%
7/23 • 1 year (12 months)
|
|
Investigations
Intraocular Pressure Increased
|
8.8%
3/34 • 1 year (12 months)
|
2.8%
1/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Investigations
Blood Triglycerides Increased
|
5.9%
2/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
2/34 • 1 year (12 months)
|
2.8%
1/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
8.7%
2/23 • 1 year (12 months)
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • 1 year (12 months)
|
8.3%
3/36 • 1 year (12 months)
|
4.3%
1/23 • 1 year (12 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.8%
3/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
4.3%
1/23 • 1 year (12 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/34 • 1 year (12 months)
|
5.6%
2/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
|
Infections and infestations
Conjunctivitis
|
5.9%
2/34 • 1 year (12 months)
|
0.00%
0/36 • 1 year (12 months)
|
0.00%
0/23 • 1 year (12 months)
|
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