Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure

Ocular Hypertension Clinical Trial

Official title:

A Phase 2, Double-masked, Randomized, Multi-center, Active-controlled, Dose-response Parallel-group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731002
• Other study ID #: AR-13324-CS202
• 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
• 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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

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