Study of AR-13324 in Patients With Elevated Intraocular Pressure

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528787
• Other study ID #: AR-13324-CS201
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2012
• Last updated: March 19, 2018
• Start date: March 2012
• Est. completion date: July 2012

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• AR-13324 Ophthalmic Solution 0.01%
Administered to study eye, once daily (QD) in the morning (AM) for 7 days
• AR-13324 Ophthalmic Solution 0.02%
Administered to study eye, QD AM for 7 days
• AR-13324 Ophthalmic Solution 0.04%
Administered to study eye, QD AM for 7 days

Other:
• AR-13324 Ophthalmic Solution Vehicle
Administered to study eye, QD AM for 7 days

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas
United States	Robert Noecker, M.D., M.B.A.	Fairfield	Connecticut
United States	Univ Eye Surgeons, Maryville Ctr.	Maryville	Tennessee
United States	Aesthetic Eye Care Institute	Newport Beach	California
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Rochester Ophthalmology Group	Rochester	New York
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Comprehensive Eye Care	Saint Louis	Missouri
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Heart of America Eye Care, P.A.	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 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.	Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.