Study of AR-13324 in Patients With Elevated Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01528787
First received: February 5, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), q.d. (AM) x 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.


Condition Intervention Phase
Ocular Hypertension
Open Angle Glaucoma
Drug: AR-13324 Ophthalmic Solution 0.01%
Drug: AR-13324 Ophthalmic Solution 0.02%
Drug: AR-13324 Ophthalmic Solution 0.04%
Drug: AR-13324 Vehicle Ophthalmic Solution
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 Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of Three Doses of AR-13324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    The primary efficacy outcome will be the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8.


Enrollment: 85
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ophthalmic solution - active or vehicle
Ophthalmic solution
Drug: AR-13324 Ophthalmic Solution 0.01%
AR-13324 Ophthalmic Solution 0.01% q.d.
Drug: AR-13324 Ophthalmic Solution 0.02%
AR-13324 Ophthalmic Solution 0.01% q.d.
Drug: AR-13324 Ophthalmic Solution 0.04%
AR-13324 Ophthalmic Solution 0.04%, q.d.
Placebo Comparator: Vehicle
AR-13324 Vehicle Ophthalmic Solution
Drug: AR-13324 Vehicle Ophthalmic Solution
AR-13324 Vehicle Ophthalmic Solution, q.d.

  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. 18 years of age or greater.
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
  3. Unmedicated (post-washout, p.r.n.) 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).
  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: 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. Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.
  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 (e.g., advanced glaucomatous optic nerve head or visual field loss).
  8. Any abnormality preventing reliable applanation tonometry in either eye. Study eye:
  9. Glaucoma: pseudoexfoliation or pigment dispersion component, history of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy. Note: Previous laser peripheral iridotomy is NOT acceptable.
  10. Previous glaucoma intraocular surgery or laser procedures such as ALT, SLT or MLT, as well as refractive procedures such as RK, LASIK, PRK, or collagen cross linking.
  11. Central corneal thickness greater than 600 μm.

    General/Systemic:

  12. Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
  13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
  14. Participation in any investigational study within the past 30 days.
  15. 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.
  16. 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: NCT01528787

Locations
United States, California
Aesthetic Eye Care Institute
Newport Beach, California, United States, 92657
United States, Connecticut
Robert Noecker, M.D., M.B.A.
Fairfield, Connecticut, United States, 06824
United States, Georgia
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
United States, Kansas
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States, 66204
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
United States, Oklahoma
The Eye Institute
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Univ Eye Surgeons, Maryville Ctr.
Maryville, Tennessee, United States, 37803
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
  More Information

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01528787     History of Changes
Other Study ID Numbers: AR-13324-CS201
Study First Received: February 5, 2012
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Intraocular pressure
visual field
Ocular hypertension or open angle glaucoma

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 October 29, 2014