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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01699464
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2b Dose-response of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months
Study Start Date : October 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3 [ Time Frame: Month 3 ]
    Intraocular pressure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  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.



  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.

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 identifier (NCT number): NCT01699464

Sponsors and Collaborators
Aerie Pharmaceuticals
Study Director: Brian Levy, OD Aerie Pharmaceuticals, Inc.

Responsible Party: Aerie Pharmaceuticals Identifier: NCT01699464     History of Changes
Other Study ID Numbers: AR-12286-CS206
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: December 2015

Keywords provided by Aerie Pharmaceuticals:

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