A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01699464
First received: October 2, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.


Condition Intervention Phase
Ocular Hypertension
Open-angle Glaucoma
Drug: AR-12286 Ophthalmic Solution 0.7%
Drug: AR-12286 Ophthalmic Solution 0.5%
Drug: Timolol maleate ophthalmic solution 0.5%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2b Dose-response of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Intraocular pressure


Enrollment: 211
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AR-12286 Ophthalmic Solution 0.7%
AR-12286 Ophthalmic Solution 0.7%, both eyes
Drug: AR-12286 Ophthalmic Solution 0.7%
Ophthalmic Solution
Experimental: AR-12286 Ophthalmic Solution 0.5%
AR-12286 Ophthalmic Solution 0.5% both eyes
Drug: AR-12286 Ophthalmic Solution 0.5%
Ophthalmic Solution
Active Comparator: Timolol maleate ophthalmic solution 0.5%
Timolol maleate ophthalmic solution 0.5% both eyes
Drug: Timolol maleate ophthalmic solution 0.5%
Ophthalmic Solution

  Eligibility

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

Inclusion Criteria:

  1. 18 year 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 (0800 hr), 2-7 days apart, and ≥ 22 mm Hg at 1000 and 1600 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. Current use of more than 1 ocular hypotensive medications (Note: fixed dose combinations are considered multiple medications).
  4. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
  5. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
  6. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
  7. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
  8. Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or a history of herpes simplex keratitis
  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. 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 µm.
  12. Any abnormality preventing reliable applanation tonometry of either eye.

    Systemic:

    Systemic:

  13. Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
  14. Known hypersensitivity or contraindication to beta adrenoceptor antagonists including chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes).
  15. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  16. Participation in any investigational study within the past 30 days.
  17. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
  18. 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: NCT01699464

Locations
United States, California
Kenneth Sall, M.D.
Artesia, California, United States, 90701
Aesthetic Eye Care Institute
Newport Beach, California, United States, 92657
Bacharach practice
Petaluma, California, United States, 94954
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, New York
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, 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
India
Vittala International Institute of Ophthalmology
Bangalore, India
Narayana Nethralaya Super Speciality Eye Hospital
Bangalore, India
Aravind Eye Hospital
Coimbatore, India
Dr. Shroff's Charity Eye Hospital
Delhi, India
AIIMS
Delhi, India
LVPEI
Hyderabad, India
CMC
Ludhiana, India
Aravind Eye Institute
Madurai, India
Conwest and Manjula S Badani Jain Hospital
Mumbai, India
Aravind Eye Hospital
Tirunelveli, India
Sponsors and Collaborators
Aerie Pharmaceuticals
  More Information

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01699464     History of Changes
Other Study ID Numbers: AR-12286-CS206
Study First Received: October 2, 2012
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Ophthalmic Solutions
Maleic acid
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014