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Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01731002
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open Angle Glaucoma Drug: AR-13324 Ophthalmic Solution 0.01% Drug: AR-13324 Ophthalmic Solution 0.02% Drug: Latanoprost ophthalmic solution 0.005% Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Latanoprost
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AR-13324 Ophthalmic Solution 0.01%
1 drop to study eye once daily
Drug: AR-13324 Ophthalmic Solution 0.01%
Administered to study eye, once daily (QD) in the evening (PM) for 28 days
Experimental: AR-13324 Ophthalmic Solution 0.02%
1 drop to study eye once daily
Drug: AR-13324 Ophthalmic Solution 0.02%
Administered to study eye, QD in the PM for 28 days
Other Name: Netarsudil
Active Comparator: Latanoprost Ophthalmic Solution 0.005%
1 drop to study eye once daily
Drug: Latanoprost ophthalmic solution 0.005%
Administered to study eye, QD in the PM for 28 days
Other Name: Latanoprost



Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 28 days ]
    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.


Secondary Outcome Measures :
  1. Extent of Exposure [ Time Frame: 28 Days ]
    Exposure to study medication in days for all treatment groups.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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) 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:

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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Saint 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
Investigators
Study Director: Theresa Heah, MD Aerie Pharmaceuticals, Inc.

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01731002     History of Changes
Other Study ID Numbers: AR-13324-CS202
First Posted: November 21, 2012    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018
Last Verified: June 2016

Keywords provided by Aerie Pharmaceuticals:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Antihypertensive Agents