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AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure

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: NCT01474135
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : September 23, 2016
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: 0.25% AR-12286 / 0.004% travoprost Drug: 0.5% AR-12286, 0.004% travoprost Drug: 0.004% Travoprost Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of Two AR 12286/Travoprost Fixed-dose Combination Products Compared to Travatan® Z in Patients With Elevated Intraocular Pressure
Study Start Date : December 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
Experimental: 0.25% AR-12286/ 0.004% travoprost
Fixed dose combination of 0.25% AR-12286 and 0.004% travoprost
Drug: 0.25% AR-12286 / 0.004% travoprost
Experimental: 0.5% AR-12286/ 0.004% travoprost
Fixed dose combination of 0.5% AR-12286/ 0.004% travoprost
Drug: 0.5% AR-12286, 0.004% travoprost
Active Comparator: 0.004%Travoprost
Travatan(R) Z(travoprost ophthalmic solution)
Drug: 0.004% Travoprost

Primary Outcome Measures :
  1. Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint. [ Time Frame: 7 days ]
    Intraocular pressure

Secondary Outcome Measures :
  1. Ocular and systemic safety [ Time Frame: 7 days ]
    Ophthalmic examination and adverse event reports

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 apart. At second eligibility visit, IOP >22 mmHg at 10:00, 12:00 and 16:00 hrs.
  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 (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 travoprost, 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.


  13. Clinically significant abnormalities in laboratory tests at screening.
  14. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  15. Participation in any investigational study within the past 30 days.
  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 status of nonclinical 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): NCT01474135

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United States, California
United Medical Research Institute
Inglewood, California, United States, 90301
Aesthetic Eye Care Institute
Newport Beach, California, United States, 92657
Bacharach practice
Petaluma, California, United States, 94954
Centre For Health Care
Poway, California, United States, 92064
United States, Missouri
Comprehensive Eye Care
St Louis, Missouri, United States, 63090
United States, New York
Rochester Ophthalmology Group
Rochester, New York, United States, 14618
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States, 12159
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
United States, Texas
Cataract & Glaucoma Center
El Paso, Texas, United States, 79902
Sponsors and Collaborators
Aerie Pharmaceuticals
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Responsible Party: Aerie Pharmaceuticals Identifier: NCT01474135    
Other Study ID Numbers: PG286-CS201
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Keywords provided by Aerie Pharmaceuticals:
Ocular Hypertension
Additional relevant MeSH terms:
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Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents