Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

24-hour Efficacy of AR-12286

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01330979
First received: April 6, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

An open-label, non-comparative, pilot evaluation of the 24-hour ocular hypotensive efficacy of AR-12286 in patients with open-angle glaucoma or ocular hypertension


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: AR-12286 0.5% Ophthalmic Solution
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Open-angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Intraocular pressure compared to baseline


Secondary Outcome Measures:
  • Intraocular pressure [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Diurnal IOP


Enrollment: 5
Study Start Date: May 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AR-12286 0.5% Ophthalmic Solution
    Ophthalmic Solution
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion criteria

    1. 40 to 80 years of age.
    2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
    3. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
    4. Able and willing to give signed informed consent and follow study instructions including two nights in UCSD sleep lab for physiological measurements.
  • Exclusion criteria

Excluded from the study will be individuals with the following characteristics:

Ophthalmic (in either eye):

  1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow irridocorneal angle. Note: Previous laser peripheral iridotomy is acceptable.
  2. Intraocular pressure > 36 mm Hg.
  3. Known hypersensitivity to 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. Current use of cigarettes.
  16. Irregular sleep schedule.
  17. Participation in any investigational study within the past 30 days.
  18. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
  19. 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: NCT01330979

Locations
United States, California
University of California
San Diego, California, United States, 92093
Sponsors and Collaborators
Aerie Pharmaceuticals
  More Information

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01330979     History of Changes
Other Study ID Numbers: AR-12286-CS204
Study First Received: April 6, 2011
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014