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A Study of AR-12286 in Patient With Elevated Intraocular Pressure (IOP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00902200
First received: May 13, 2009
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286.


Condition Intervention Phase
Elevated Intraocular Pressure
Drug: AR-12286
Drug: AR-12286 vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 Ophthalmic Solution 0.05%, 0.1% and 0.25% 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 mean diurnal IOP on each day at which diurnal IOP is measured at each timepoint. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle
q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
Drug: AR-12286 vehicle
See arms
Experimental: AR-12286 0.05%
q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
Drug: AR-12286
See arms
Experimental: AR-12286 0.1%
q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
Drug: AR-12286
See arms
Experimental: AR-12286 0.25%
q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days.
Drug: AR-12286
See arms

Detailed Description:

Subjects will be randomized to receive AR-12286 Ophthalmic Solution 0.05%, 0.1%, and 0.25% or its vehicle (one eye), q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. The first dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout this period.

  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). Unmedicated (post-washout, if required) IOP >= 24 mm Hg in one or both eyes at 08:00 hours, >= 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).
  3. Corrected visual acuity in each eye +1.0 logMAR (logarithm mininum angle of resolution) or better by ETDRS (Early Treatment Diabetic Retinopathy Study) in each eye (equivalent to 20/200).
  4. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Either eye

  1. Intraocular pressure > 36 mm Hg
  2. Known hypersensitivity to any component of the formulation or to topical anesthetics, (benzalkonium chloride, etc.)
  3. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
  4. History or evidence of ocular infection inflammation, or of herpes simplex keratitis, or clinically significant blepharitis or conjunctivitis at baseline (Visit 1)..
  5. Contact lens wear within 30 minutes of instillation of study medication.
  6. Ocular medication of any kind within 30 days of Visit 2, 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 2) or c) lubricating drops for dry eye (which may be used throughout the study),
  7. 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).
  8. Central corneal thickness greater than 600 microns.
  9. Any abnormality preventing reliable applanation tonometry.

    Study eye:

  10. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure.

    Note: Previous laser peripheral iridotomy is acceptable.

  11. Previous glaucoma intraocular surgery or laser procedures in study eye(s).
  12. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (Laser-Assisted in situ Keratomileusis), etc.).

    General/Systemic:

  13. Clinically significant abnormalities in laboratory tests at screening (See Appendix 1).
  14. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
  15. Participation in any investigational study within the past 30 days.
  16. Changes of systemic medication during the study that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
  17. 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: NCT00902200

Locations
United States, California
Soilsh Practice
Pasadena, California, United States, 91105
Bacharach practice
Petaluma, California, United States, 94954
United States, Florida
Hernando Eye Institute
Brooksville, Florida, United States, 34613
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, North Carolina
Mundorf Practice
Charlotte, North Carolina, United States, 28204
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Texan Eye
Austin, Texas, United States, 78731
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
Study Director: Tom van Haarlem, MD Aerie Pharmaceuticals, Inc.
  More Information

No publications provided by Aerie Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00902200     History of Changes
Other Study ID Numbers: AR-12286-CS201
Study First Received: May 13, 2009
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma
Intraocular pressure

ClinicalTrials.gov processed this record on November 20, 2014