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

• Sponsor: Aerie Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01060579
• Collaborator: (none)
• Enrollment: 217
• Locations: 18
• Arms: 3
• Duration (Months): 5.9
• Patients Per Site: 12.1
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: AR-12286 0.5% ophthalmic solution; Drug: AR-12286 0.25% Ophthalmic solution; Drug: Latanoprost ophthalmic solution	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AR-12286 0.5% ophthalmic solution	Drug: AR-12286 0.5% ophthalmic solution; q.d. PM
Experimental: AR-12286 0.25% Ophthalmic Solution	Drug: AR-12286 0.25% Ophthalmic solution; q.d. PM
Experimental: Latanoprost 0.005% ophthalmic solution	Drug: Latanoprost ophthalmic solution; q.d. PM; Other Names: Xalatan(R)

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Mean change from diurnally adjusted baseline IOP at each timepoint [28 days of dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Medical Research Institute	Inglewood	California	United States	90301
2	North Bay Eye Associates	Petaluma	California	United States	94954
3	Centre For Health Care	Poway	California	United States	92064
4	East Florida Eye Institute	Stuart	Florida	United States	34994
5	Marvin Greenberg, MD	Tamarac	Florida	United States	33321
6	Coastal Research Associates, LLC	Roswell	Georgia	United States	30076
7	Bradley Kwapiszeski, MD	Shawnee Mission	Kansas	United States	66204
8	Taustine Eye Center	Louisville	Kentucky	United States	40217
9	Comprehensive Eye Care	St Louis	Missouri	United States	63090
10	Mount Sinai School Of Medicine	New York	New York	United States	10029
11	Rochester Ophthalmology Group	Rochester	New York	United States	14618
12	Glaucoma Consultants of the Capital Region	Slingerlands	New York	United States	12159
13	Charlotte Eye Ear Nose and Throat	Charlotte	North Carolina	United States	28210
14	The Eye Institute	Tulsa	Oklahoma	United States	74104
15	Black Hills Regional Eye Institute	Rapid City	South Dakota	United States	57701
16	Univ Eye Surgeons, Maryville Ctr.	Maryville	Tennessee	United States	37803
17	Texan Eye	Austin	Texas	United States	78731
18	Medical Center Ophth. Associates	San Antonio	Texas	United States	78731

Sponsors and Collaborators

• Aerie Pharmaceuticals

Investigators

• Study Director: Thomas van Haarlem, MD, Aerie Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aerie Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01060579
• Other Study ID Numbers: AR-12286-CS202
• First Posted: Feb 2, 2010
• Last Update Posted: May 8, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Aerie Pharmaceuticals: Glaucoma
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions

Study Results

No Results Posted as of May 8, 2014