Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01060579
First received: January 30, 2010
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.


Condition Intervention Phase
Glaucoma
Drug: AR-12286 0.5% ophthalmic solution
Drug: AR-12286 0.25% Ophthalmic solution
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, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint [ Time Frame: 28 days of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from diurnally adjusted baseline IOP at each timepoint [ Time Frame: 28 days of dosing ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AR-12286 0.5% ophthalmic solution
None.
Drug: AR-12286 0.5% ophthalmic solution
q.d. PM
Experimental: AR-12286 0.25% Ophthalmic Solution
None
Drug: AR-12286 0.25% Ophthalmic solution
q.d. PM
Experimental: Latanoprost 0.005% ophthalmic solution
None.
Drug: Latanoprost ophthalmic solution
q.d. PM
Other Name: Xalatan(R)

  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) and currently being treated with ocular hypotensive medication.
  3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
  4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
  5. Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.
  6. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic (in either eye):

  1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
  2. Intraocular pressure > 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).
  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.
  7. History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
  8. Contact lens wear within 30 minutes of instillation of study medication.
  9. Ocular medication of any kind within 30 days of Visit 1, 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 1) or c) lubricating drops for dry eye (which may be used throughout the study).
  10. 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).
  11. Central corneal thickness greater than 600 μ.
  12. Any abnormality preventing reliable applanation tonometry of either eye.

Systemic:

  1. Clinically significant abnormalities in laboratory tests at screening.
  2. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  3. Participation in any investigational study within the past 30 days.
  4. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
  5. Due to status of 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: NCT01060579

Locations
United States, California
United Medical Research Institute
Inglewood, California, United States, 90301
North Bay Eye Associates
Petaluma, California, United States, 94954
Centre For Health Care
Poway, California, United States, 92064
United States, Florida
East Florida Eye Institute
Stuart, Florida, United States, 34994
Marvin Greenberg, MD
Tamarac, Florida, United States, 33321
United States, Georgia
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, Missouri
Comprehensive Eye Care
St Louis, Missouri, United States, 63090
United States, New York
Mount Sinai School Of Medicine
New York, New York, United States, 10029
Rochester Ophthalmology Group
Rochester, New York, United States, 14618
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States, 12159
United States, North Carolina
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
The Eye Institute
Tulsa, Oklahoma, United States, 74104
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Univ Eye Surgeons, Maryville Ctr.
Maryville, Tennessee, United States, 37803
United States, Texas
Texan Eye
Austin, Texas, United States, 78731
Medical Center Ophth. Associates
San Antonio, Texas, United States, 78731
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
Study Director: Thomas van Haarlem, MD Aerie Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01060579     History of Changes
Other Study ID Numbers: AR-12286-CS202
Study First Received: January 30, 2010
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014