Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
A Phase 2, Double-masked, Randomized, Multi-center, Active-controlled, Dose-response Parallel-group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
1 other identifier
interventional
224
1 country
22
Brief Summary
Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 15, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
April 17, 2018
CompletedApril 17, 2018
June 1, 2016
6 months
November 15, 2012
January 22, 2018
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure (IOP)
The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.
Study treatment was administered for 28 days
Secondary Outcomes (1)
Extent of Exposure
28 Days
Study Arms (3)
AR-13324 Ophthalmic Solution 0.01%
EXPERIMENTAL1 drop to study eye once daily
AR-13324 Ophthalmic Solution 0.02%
EXPERIMENTAL1 drop to study eye once daily
Latanoprost Ophthalmic Solution 0.005%
ACTIVE COMPARATOR1 drop to study eye once daily
Interventions
Administered to study eye, once daily (QD) in the evening (PM) for 28 days
Administered to study eye, QD in the PM for 28 days
Administered to study eye, QD in the PM for 28 days
Eligibility Criteria
You may qualify if:
- years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) Intraocular Pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days a part, and ≥ 22 mm Hg at 10:00 and 16:00 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints.
- 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.
You may not qualify if:
- Ophthalmic
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
- IOP \> 36 mm Hg.
- Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s, e.g., laser trabeculoplasty).
- Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser eye surgery (LASIK), etc.).
- Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months prior to screening.
- Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis
- Ocular medication of any kind within 30 days of Visit 0, 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 0) or c) lubricating drops for dry eye (which may be used throughout the study).
- Clinically significant ocular disease (e.g. 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 µm.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Systemic:
- Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
- Known hypersensitivity or contraindication to latanoprost.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Kenneth Sall, M.D.
Artesia, California, 90701, United States
United Medical Research Institute
Inglewood, California, 90301, United States
Aesthetic Eye Care Institute
Newport Beach, California, 92657, United States
North Bay Eye Associates
Petaluma, California, 94954, United States
Centre For Health Care
Poway, California, 92064, United States
Clayton Eye Center
Morrow, Georgia, 30260, United States
Coastal Research Associates, LLC
Roswell, Georgia, 30076, United States
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, 66204, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Alan L Robin, M.D.
Baltimore, Maryland, 21209, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078, United States
Great Lakes Eye Care
Saint Joseph, Michigan, 49085, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Rochester Ophthalmological Group
Rochester, New York, 14618, United States
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, 28210, United States
Michael E. Tepedino, M.D.
High Point, North Carolina, 27262, United States
The Eye Institute
Tulsa, Oklahoma, 74104, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Texan Eye
Austin, Texas, 78731, United States
Cataract & Glaucoma Center
El Paso, Texas, 79902, United States
Medical Center Ophth. Associates
San Antonio, Texas, 78731, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nancy Ramirez-Davis, Director of Clinical Project Management
- Organization
- Aerie Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Theresa Heah, MD
Aerie Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
November 15, 2012
First Posted
November 21, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
April 17, 2018
Results First Posted
April 17, 2018
Record last verified: 2016-06