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Study of AR-13324 in Patients With Elevated Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01528787
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : February 21, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
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), once daily (QD)in the morning (AM) for 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 or disease Intervention/treatment 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% Other: AR-13324 Ophthalmic Solution Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Three Doses of AR-13324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Study Start Date : March 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AR-13324 Ophthalmic Solution 0.01%
1 drop to study eye once daily
Drug: AR-13324 Ophthalmic Solution 0.01%
Administered to study eye, once daily (QD) in the morning (AM) for 7 days
Experimental: AR-13324 Ophthalmic Solution 0.02%
1 drop to study eye once daily
Drug: AR-13324 Ophthalmic Solution 0.02%
Administered to study eye, QD AM for 7 days
Other Name: Netarsudil
Experimental: AR-13324 Ophthalmic Solution 0.04%
1 drop to study eye once daily
Drug: AR-13324 Ophthalmic Solution 0.04%
Administered to study eye, QD AM for 7 days
Placebo Comparator: AR-13324 Ophthalmic Solution Vehicle
1 drop to study eye once daily
Other: AR-13324 Ophthalmic Solution Vehicle
Administered to study eye, QD AM for 7 days



Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8. ]

    The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8.

    Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.




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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 argon laser trabeculoplasty (ALT), selective laser trabeculoplasty (SLT) or micropulse laser trabeculoplasty ( MLT), as well as refractive procedures such as radio keratotomy (RK), laser eye surgery (LASIK), photorefractive keratectomy (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.

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 ClinicalTrials.gov identifier (NCT number): 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
Saint 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
Investigators
Study Director: Theresa Heah, MD Aerie Pharmaceuticals, Inc.

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01528787     History of Changes
Other Study ID Numbers: AR-13324-CS201
First Posted: February 8, 2012    Key Record Dates
Results First Posted: February 21, 2018
Last Update Posted: April 18, 2018
Last Verified: June 2016

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

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