Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure

Glaucoma Clinical Trial

Official title:

A Phase 2, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060579
• Other study ID #: AR-12286-CS202
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2010
• Last updated: April 18, 2014
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: April 2014
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or greater.

2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.

3. Unmedicated (post-washout) IOP = 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.

4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).

5. Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.

6. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic (in either eye):

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.

2. Intraocular pressure > 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).

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

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

7. History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis

8. Contact lens wear within 30 minutes of instillation of study medication.

9. Ocular medication of any kind within 30 days of Visit 1, 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 1) or c) lubricating drops for dry eye (which may be used throughout the study).

10. 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 (i.e., cup-disc ratio > 0.8).

11. Central corneal thickness greater than 600 µ.

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

Systemic:

1. Clinically significant abnormalities in laboratory tests at screening.

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

3. Participation in any investigational study within the past 30 days.

4. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.

5. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• AR-12286 0.5% ophthalmic solution
q.d. PM
• AR-12286 0.25% Ophthalmic solution
q.d. PM
• Latanoprost ophthalmic solution
q.d. PM

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas
United States	Charlotte Eye Ear Nose and Throat	Charlotte	North Carolina
United States	United Medical Research Institute	Inglewood	California
United States	Taustine Eye Center	Louisville	Kentucky
United States	Univ Eye Surgeons, Maryville Ctr.	Maryville	Tennessee
United States	Mount Sinai School Of Medicine	New York	New York
United States	North Bay Eye Associates	Petaluma	California
United States	Centre For Health Care	Poway	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Rochester Ophthalmology Group	Rochester	New York
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Medical Center Ophth. Associates	San Antonio	Texas
United States	Bradley Kwapiszeski, MD	Shawnee Mission	Kansas
United States	Glaucoma Consultants of the Capital Region	Slingerlands	New York
United States	Comprehensive Eye Care	St Louis	Missouri
United States	East Florida Eye Institute	Stuart	Florida
United States	Marvin Greenberg, MD	Tamarac	Florida
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	The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint		28 days of dosing	No
Secondary	Mean change from diurnally adjusted baseline IOP at each timepoint		28 days of dosing	No