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
1 other identifier
interventional
89
1 country
8
Brief Summary
Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2009
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedApril 21, 2014
March 1, 2014
4 months
May 13, 2009
March 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint will be mean diurnal IOP on each day at which diurnal IOP is measured at each timepoint.
3 weeks
Study Arms (4)
Vehicle
PLACEBO COMPARATORq.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
AR-12286 0.05%
EXPERIMENTALq.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
AR-12286 0.1%
EXPERIMENTALq.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
AR-12286 0.25%
EXPERIMENTALq.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Soilsh Practice
Pasadena, California, 91105, United States
Bacharach practice
Petaluma, California, 94954, United States
Hernando Eye Institute
Brooksville, Florida, 34613, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Mundorf Practice
Charlotte, North Carolina, 28204, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Texan Eye
Austin, Texas, 78731, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Related Publications (1)
Williams RD, Novack GD, van Haarlem T, Kopczynski C; AR-12286 Phase 2A Study Group. Ocular hypotensive effect of the Rho kinase inhibitor AR-12286 in patients with glaucoma and ocular hypertension. Am J Ophthalmol. 2011 Nov;152(5):834-41.e1. doi: 10.1016/j.ajo.2011.04.012. Epub 2011 Jul 27.
PMID: 21794845DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tom van Haarlem, MD
Aerie Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 15, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
April 21, 2014
Record last verified: 2014-03