Study of AR-13324 in Patients With Elevated Intraocular Pressure
Study Details
Study Description
Brief Summary
In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AR-13324 Ophthalmic Solution 0.01% 1 drop to study eye once daily |
Drug: AR-13324 Ophthalmic Solution 0.01%
Administered to study eye, once daily (QD) in the morning (AM) for 7 days
|
| Experimental: AR-13324 Ophthalmic Solution 0.02% 1 drop to study eye once daily |
Drug: AR-13324 Ophthalmic Solution 0.02%
Administered to study eye, QD AM for 7 days
Other Names:
|
| Experimental: AR-13324 Ophthalmic Solution 0.04% 1 drop to study eye once daily |
Drug: AR-13324 Ophthalmic Solution 0.04%
Administered to study eye, QD AM for 7 days
|
| Placebo Comparator: AR-13324 Ophthalmic Solution Vehicle 1 drop to study eye once daily |
Other: AR-13324 Ophthalmic Solution Vehicle
Administered to study eye, QD AM for 7 days
|
Outcome Measures
Primary Outcome Measures
- Intraocular Pressure (IOP) [Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or greater. 18 years of age or greater.
-
Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
-
Unmedicated (post-washout, p.r.n.) IOP ≥ 24 mm Hg in one or both eyes at 08:00 hours, ≥ 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).
-
Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
-
Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria:
Ophthalmic: Either eye
-
Intraocular pressure > 36 mm Hg
-
Known hypersensitivity to any component of the formulation or to topical anesthetics, (benzalkonium chloride, etc.)
-
Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
-
Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.
-
Contact lens wear within 30 minutes of instillation of study medication.
-
Ocular medication of any kind within 30 days of Visit 2, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 2) or c) lubricating drops for dry eye (which may be used throughout the study),
-
Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
-
Any abnormality preventing reliable applanation tonometry in either eye. Study eye:
-
Glaucoma: pseudoexfoliation or pigment dispersion component, history of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy. Note: Previous laser peripheral iridotomy is NOT acceptable.
-
Previous glaucoma intraocular surgery or laser procedures such as argon laser trabeculoplasty (ALT), selective laser trabeculoplasty (SLT) or micropulse laser trabeculoplasty ( MLT), as well as refractive procedures such as radio keratotomy (RK), laser eye surgery (LASIK), photorefractive keratectomy (PRK), or collagen cross linking.
-
Central corneal thickness greater than 600 μm.
General/Systemic:
-
Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
-
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
-
Participation in any investigational study within the past 30 days.
-
Changes of systemic medication during the study that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
-
Due to status of preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aesthetic Eye Care Institute | Newport Beach | California | United States | 92657 |
| 2 | Robert Noecker, M.D., M.B.A. | Fairfield | Connecticut | United States | 06824 |
| 3 | Coastal Research Associates, LLC | Roswell | Georgia | United States | 30076 |
| 4 | Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | United States | 66204 |
| 5 | Comprehensive Eye Care | Saint Louis | Missouri | United States | 63090 |
| 6 | Rochester Ophthalmology Group | Rochester | New York | United States | 14618 |
| 7 | The Eye Institute | Tulsa | Oklahoma | United States | 74104 |
| 8 | Wills Eye Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 9 | Univ Eye Surgeons, Maryville Ctr. | Maryville | Tennessee | United States | 37803 |
| 10 | Texan Eye | Austin | Texas | United States | 78731 |
| 11 | Medical Center Ophthalmology Associates | San Antonio | Texas | United States | 78240 |
Sponsors and Collaborators
- Aerie Pharmaceuticals
Investigators
- Study Director: Theresa Heah, MD, Aerie Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AR-13324-CS201
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | AR-13324 Ophthalmic Solution 0.01% | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Opththalmic Solution Vehicle |
|---|---|---|---|---|
| Arm/Group Description | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) |
| Period Title: Overall Study | ||||
| STARTED | 22 | 21 | 19 | 23 |
| COMPLETED | 22 | 21 | 18 | 22 |
| NOT COMPLETED | 0 | 0 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | AR-13324 Ophthalmic Solution 0.01% | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution Vehicle | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | Total of all reporting groups |
| Overall Participants | 22 | 21 | 19 | 23 | 85 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
63.6
(12.36)
|
69.1
(8.69)
|
66.1
(11.09)
|
57.8
(12.27)
|
64.0
(11.83)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
14
63.6%
|
14
66.7%
|
10
52.6%
|
13
56.5%
|
51
60%
|
| Male |
8
36.4%
|
7
33.3%
|
9
47.4%
|
10
43.5%
|
34
40%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
4
18.2%
|
1
4.8%
|
2
10.5%
|
4
17.4%
|
11
12.9%
|
| Not Hispanic or Latino |
18
81.8%
|
20
95.2%
|
17
89.5%
|
19
82.6%
|
74
87.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
4.5%
|
1
4.8%
|
0
0%
|
1
4.3%
|
3
3.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
4.5%
|
3
14.3%
|
2
10.5%
|
2
8.7%
|
8
9.4%
|
| White |
20
90.9%
|
17
81%
|
17
89.5%
|
20
87%
|
74
87.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Intraocular Pressure (IOP) |
|---|---|
| Description | 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. |
| Time Frame | Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | AR-13324 Ophthalmic Solution 0.01% | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution Vehicle |
|---|---|---|---|---|
| Arm/Group Description | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) |
| Measure Participants | 22 | 21 | 19 | 23 |
| Day 2, 0800 hours |
25.80
(3.699)
|
26.02
(2.542)
|
26.50
(3.358)
|
25.17
(2.980)
|
| Day 2, 1000 hours |
22.45
(3.713)
|
22.10
(3.149)
|
24.29
(5.347)
|
22.87
(2.681)
|
| Day 2, 1200 hours |
21.93
(2.997)
|
21.95
(3.653)
|
25.00
(5.292)
|
22.91
(2.863)
|
| Day 2, 1600 hours |
20.70
(3.521)
|
20.88
(3.467)
|
22.29
(4.849)
|
21.41
(3.110)
|
| Day 4, 0800 hours |
21.32
(4.049)
|
21.00
(4.530)
|
22.00
(5.352)
|
23.98
(3.730)
|
| Day 8, 0800 hours |
20.82
(5.487)
|
20.60
(3.491)
|
20.44
(3.933)
|
24.34
(3.663)
|
| Day 8, 1000 hours |
18.20
(4.165)
|
18.71
(3.208)
|
19.42
(3.663)
|
22.34
(4.034)
|
| Day 8, 1200 hours |
17.57
(4.255)
|
17.88
(3.457)
|
18.78
(4.486)
|
21.93
(3.818)
|
| Day 8, 1600 hours |
17.68
(3.161)
|
16.88
(3.049)
|
17.83
(3.510)
|
21.52
(4.244)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | AR-13324 Ophthalmic Solution 0.01% | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution Vehicle | ||||
| Arm/Group Description | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | 1 drop to study eye once daily (QD) in the morning (AM) | ||||
All Cause Mortality |
||||||||
| AR-13324 Ophthalmic Solution 0.01% | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution Vehicle | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/21 (0%) | 0/19 (0%) | 0/23 (0%) | ||||
Serious Adverse Events |
||||||||
| AR-13324 Ophthalmic Solution 0.01% | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution Vehicle | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/21 (0%) | 0/19 (0%) | 0/23 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| AR-13324 Ophthalmic Solution 0.01% | AR-13324 Ophthalmic Solution 0.02% | AR-13324 Ophthalmic Solution 0.04% | AR-13324 Ophthalmic Solution Vehicle | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/22 (54.5%) | 15/21 (71.4%) | 17/19 (89.5%) | 1/23 (4.3%) | ||||
| Ear and labyrinth disorders | ||||||||
| Vertigo | 0/22 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/23 (0%) | ||||
| Eye disorders | ||||||||
| Conjunctival Hyperaemia | 11/22 (50%) | 12/21 (57.1%) | 14/19 (73.7%) | 1/23 (4.3%) | ||||
| Ocular Hyperaemia | 1/22 (4.5%) | 1/21 (4.8%) | 3/19 (15.8%) | 0/23 (0%) | ||||
| Erythema of Eyelid | 0/22 (0%) | 1/21 (4.8%) | 1/19 (5.3%) | 0/23 (0%) | ||||
| Vision Blurred | 0/22 (0%) | 2/21 (9.5%) | 1/19 (5.3%) | 0/23 (0%) | ||||
| Diplopia | 0/22 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/23 (0%) | ||||
| Dry Eye | 0/22 (0%) | 2/21 (9.5%) | 0/19 (0%) | 0/23 (0%) | ||||
| Vitreous Floaters | 0/22 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/23 (0%) | ||||
| General disorders | ||||||||
| Instillation Site Reaction | 0/22 (0%) | 0/21 (0%) | 2/19 (10.5%) | 0/23 (0%) | ||||
| Investigations | ||||||||
| Corneal Staining | 0/22 (0%) | 2/21 (9.5%) | 1/19 (5.3%) | 0/23 (0%) | ||||
| Blood Glucose Increased | 0/22 (0%) | 1/21 (4.8%) | 1/19 (5.3%) | 0/23 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nancy Ramirez-Davis, Director Clinical Project Management |
|---|---|
| Organization | Aerie Pharmaceuticals, Inc. |
| Phone | 908-947-3543 |
| nramirez@aeriepharma.com |
- AR-13324-CS201