Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
NCT ID: NCT01731002
Last Updated: 2018-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2012-11-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AR-13324 Ophthalmic Solution 0.01%
1 drop to study eye once daily
AR-13324 Ophthalmic Solution 0.01%
Administered to study eye, once daily (QD) in the evening (PM) for 28 days
AR-13324 Ophthalmic Solution 0.02%
1 drop to study eye once daily
AR-13324 Ophthalmic Solution 0.02%
Administered to study eye, QD in the PM for 28 days
Latanoprost Ophthalmic Solution 0.005%
1 drop to study eye once daily
Latanoprost ophthalmic solution 0.005%
Administered to study eye, QD in the PM for 28 days
Interventions
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AR-13324 Ophthalmic Solution 0.01%
Administered to study eye, once daily (QD) in the evening (PM) for 28 days
AR-13324 Ophthalmic Solution 0.02%
Administered to study eye, QD in the PM for 28 days
Latanoprost ophthalmic solution 0.005%
Administered to study eye, QD in the PM for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. 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.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria
1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
2. IOP \> 36 mm Hg.
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s, e.g., laser trabeculoplasty).
5. Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser eye surgery (LASIK), etc.).
6. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months prior to screening.
7. Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis
8. 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).
9. 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).
10. Central corneal thickness greater than 600 µm.
11. Any abnormality preventing reliable applanation tonometry of either eye.
Systemic:
12. Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
13. Known hypersensitivity or contraindication to latanoprost.
14. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
15. Participation in any investigational study within 30 days prior to screening.
16. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
17. Due to the current status of the 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.
18 Years
99 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Theresa Heah, MD
Role: STUDY_DIRECTOR
Aerie Pharmaceuticals, Inc.
Locations
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Kenneth Sall, M.D.
Artesia, California, United States
United Medical Research Institute
Inglewood, California, United States
Aesthetic Eye Care Institute
Newport Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
Centre For Health Care
Poway, California, United States
Clayton Eye Center
Morrow, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, United States
Taustine Eye Center
Louisville, Kentucky, United States
Alan L Robin, M.D.
Baltimore, Maryland, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Great Lakes Eye Care
Saint Joseph, Michigan, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Rochester Ophthalmological Group
Rochester, New York, United States
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, United States
Michael E. Tepedino, M.D.
High Point, North Carolina, United States
The Eye Institute
Tulsa, Oklahoma, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Texan Eye
Austin, Texas, United States
Cataract & Glaucoma Center
El Paso, Texas, United States
Medical Center Ophth. Associates
San Antonio, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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Other Identifiers
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AR-13324-CS202
Identifier Type: -
Identifier Source: org_study_id
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