AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01474135
First received: November 11, 2011
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Intraocular pressure


Secondary Outcome Measures:
  • Ocular and systemic safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Ophthalmic examination and adverse event reports


Enrollment: 93
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
None
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
None
Active Comparator: 0.004%Travoprost
Travatan(R) Z(travoprost ophthalmic solution)
Drug: 0.004% Travoprost
None

  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).
  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.

    Systemic:

  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.

    -

  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: NCT01474135

Locations
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
  More Information

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01474135     History of Changes
Other Study ID Numbers: PG286-CS201
Study First Received: November 11, 2011
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Cloprostenol
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014