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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01731002
Other study ID # AR-13324-CS202
Secondary ID
Status Completed
Phase Phase 2
First received November 15, 2012
Last updated March 19, 2018
Start date November 2012
Est. completion date May 2013

Study information

Verified date June 2016
Source Aerie Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost


Recruitment information / eligibility

Status Completed
Enrollment 224
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

1. 18 years of age or greater.

2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

3. Unmedicated (post-washout) Intraocular Pressure (IOP) = 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days a part, and = 22 mm Hg at 10:00 and 16:00 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints.

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

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.

2. IOP > 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, e.g., laser trabeculoplasty).

5. Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser eye surgery (LASIK), etc.).

6. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months prior to screening.

7. Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis

8. Ocular medication of any kind within 30 days of Visit 0, 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 0) or c) lubricating drops for dry eye (which may be used throughout the study).

9. Clinically significant ocular disease (e.g. 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).

10. Central corneal thickness greater than 600 µm.

11. Any abnormality preventing reliable applanation tonometry of either eye.

Systemic:

12. Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.

13. Known hypersensitivity or contraindication to latanoprost.

14. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.

15. Participation in any investigational study within 30 days prior to screening.

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 the current status of the 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.

Study Design


Intervention

Drug:
AR-13324 Ophthalmic Solution 0.01%
Administered to study eye, once daily (QD) in the evening (PM) for 28 days
AR-13324 Ophthalmic Solution 0.02%
Administered to study eye, QD in the PM for 28 days
Latanoprost ophthalmic solution 0.005%
Administered to study eye, QD in the PM for 28 days

Locations

Country Name City State
United States Kenneth Sall, M.D. Artesia California
United States Texan Eye Austin Texas
United States Alan L Robin, M.D. Baltimore Maryland
United States Charlotte Eye Ear Nose and Throat Charlotte North Carolina
United States Cataract & Glaucoma Center El Paso Texas
United States Seidenberg Protzko Eye Associates Havre De Grace Maryland
United States Michael E. Tepedino, M.D. High Point North Carolina
United States United Medical Research Institute Inglewood California
United States Taustine Eye Center Louisville Kentucky
United States Ophthalmic Consultants of Long Island Lynbrook New York
United States Clayton Eye Center Morrow Georgia
United States Aesthetic Eye Care Institute Newport Beach California
United States Virginia Eye Consultants Norfolk Virginia
United States North Bay Eye Associates Petaluma California
United States Wills Eye Hospital Philadelphia Pennsylvania
United States Centre For Health Care Poway California
United States Rochester Ophthalmological Group Rochester New York
United States Coastal Research Associates, LLC Roswell Georgia
United States Great Lakes Eye Care Saint Joseph Michigan
United States Medical Center Ophth. Associates San Antonio Texas
United States Bradley Kwapiszeski, MD Shawnee Mission Kansas
United States The Eye Institute Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30. Study treatment was administered for 28 days
Secondary Extent of Exposure Exposure to study medication in days for all treatment groups. 28 Days
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