- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00902200
A Study of AR-12286 in Patient With Elevated Intraocular Pressure (IOP)
A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 Ophthalmic Solution 0.05%, 0.1% and 0.25% in Patients With Elevated Intraocular Pressure
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Pasadena, California, United States, 91105
- Soilsh Practice
-
Petaluma, California, United States, 94954
- Bacharach practice
-
-
Florida
-
Brooksville, Florida, United States, 34613
- Hernando Eye Institute
-
-
Kentucky
-
Louisville, Kentucky, United States, 40217
- Taustine Eye Center
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Mundorf Practice
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Black Hills Regional Eye Institute
-
-
Texas
-
Austin, Texas, United States, 78731
- Texan Eye
-
San Antonio, Texas, United States, 78240
- Medical Center Ophthalmology Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). Unmedicated (post-washout, if required) 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 (logarithm mininum angle of resolution) or better by ETDRS (Early Treatment Diabetic Retinopathy Study) in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria:
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.
- History or evidence of ocular infection inflammation, or of herpes simplex keratitis, or clinically significant blepharitis or conjunctivitis at baseline (Visit 1)..
- 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 (i.e., cup-disc ratio > 0.8).
- Central corneal thickness greater than 600 microns.
Any abnormality preventing reliable applanation tonometry.
Study eye:
Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure.
Note: Previous laser peripheral iridotomy is acceptable.
- Previous glaucoma intraocular surgery or laser procedures in study eye(s).
Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (Laser-Assisted in situ Keratomileusis), etc.).
General/Systemic:
- Clinically significant abnormalities in laboratory tests at screening (See Appendix 1).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle
q.d.
(AM) x 7 days, then q.d.
(PM) x 7 days, then b.i.d.
x 7 days.
|
See arms
|
Experimental: AR-12286 0.05%
q.d.
(AM) x 7 days, then q.d.
(PM) x 7 days, then b.i.d.
x 7 days.
|
See arms
|
Experimental: AR-12286 0.1%
q.d.
(AM) x 7 days, then q.d.
(PM) x 7 days, then b.i.d.
x 7 days.
|
See arms
|
Experimental: AR-12286 0.25%
q.d.
(AM) x 7 days, then q.d.
(PM) x 7 days, then b.i.d.
x 7 days.
|
See arms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy endpoint will be mean diurnal IOP on each day at which diurnal IOP is measured at each timepoint.
Time Frame: 3 weeks
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tom van Haarlem, MD, Aerie Pharmaceuticals, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AR-12286-CS201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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