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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01731002
First received: November 15, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost


Condition Intervention Phase
Ocular Hypertension
Open Angle Glaucoma
Drug: AR-13324 Ophthalmic Solution 0.01%
Drug: AR-13324 Ophthalmic Solution 0.02%
Drug: Latanoprost ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • IOP [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the mean IOP across subjects within treatment group on each day at each post-treatment timepoint, excluding Days 29 and 30


Enrollment: 224
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AR-13324 Ophthalmic Solution 0.01%
AR-13324 Ophthalmic Solution 0.01%
Drug: AR-13324 Ophthalmic Solution 0.01%
N/A
Experimental: AR-13324 Ophthalmic Solution 0.02%
AR-13324 Ophthalmic Solution 0.02%
Drug: AR-13324 Ophthalmic Solution 0.02%
N/A
Active Comparator: Latanoprost
Latanoprost ophthalmic solution
Drug: Latanoprost ophthalmic solution
None

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or greater.
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
  3. Unmedicated (post-washout) 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:

Ophthalmic

  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, PRK, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731002

Locations
United States, California
Kenneth Sall, M.D.
Artesia, California, United States, 90701
United Medical Research Institute
Inglewood, California, United States, 90301
Aesthetic Eye Care Institute
Newport Beach, California, United States, 92657
North Bay Eye Associates
Petaluma, California, United States, 94954
Centre For Health Care
Poway, California, United States, 92064
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
United States, Kansas
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, Maryland
Alan L Robin, M.D.
Baltimore, Maryland, United States, 21209
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States, 21078
United States, Michigan
Great Lakes Eye Care
St Joseph, Michigan, United States, 49085
United States, New York
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Rochester Ophthalmological Group
Rochester, New York, United States, 14618
United States, North Carolina
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, United States, 28210
Michael E. Tepedino, M.D.
High Point, North Carolina, United States, 27262
United States, Oklahoma
The Eye Institute
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Texan Eye
Austin, Texas, United States, 78731
Cataract & Glaucoma Center
El Paso, Texas, United States, 79902
Medical Center Ophth. Associates
San Antonio, Texas, United States, 78731
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Aerie Pharmaceuticals
  More Information

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01731002     History of Changes
Other Study ID Numbers: AR-13324-CS202
Study First Received: November 15, 2012
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Latanoprost
Antihypertensive Agents
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014