## Protocol Section
### Identification Module
**NCT ID:** NCT01060579

**Brief Title:** Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure

**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

#### Organization Study ID Info
**ID:** AR-12286-CS202
#### Organization
**Class:** INDUSTRY
**Full Name:** Aerie Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2014-04-21

**Type:** ESTIMATED

**Disp First Submit Date:** 2014-02-17
**Disp First Submit QC Date:** 2014-03-25

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-05-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-08

**Type:** ACTUAL

#### Start Date
**Date:** 2010-02

**Status Verified Date:** 2014-04

#### Study First Post Date
**Date:** 2010-02-02
**Type:** ESTIMATED
**Study First Submit Date:** 2010-01-30
**Study First Submit QC Date:** 2010-02-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Aerie Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Glaucoma

**Keywords:**

- Glaucoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 217

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: AR-12286 0.5% ophthalmic solution

**Label:** AR-12286 0.5% ophthalmic solution

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: AR-12286 0.25% Ophthalmic solution

**Label:** AR-12286 0.25% Ophthalmic Solution

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Drug: Latanoprost ophthalmic solution

**Label:** Latanoprost 0.005% ophthalmic solution

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AR-12286 0.5% ophthalmic solution

**Description:** q.d. PM

**Name:** AR-12286 0.5% ophthalmic solution

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- AR-12286 0.25% Ophthalmic Solution

**Description:** q.d. PM

**Name:** AR-12286 0.25% Ophthalmic solution

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Latanoprost 0.005% ophthalmic solution

**Description:** q.d. PM

**Name:** Latanoprost ophthalmic solution

**Other Names:**

- Xalatan(R)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint

**Time Frame:** 28 days of dosing

#### Secondary Outcomes

**Measure:** Mean change from diurnally adjusted baseline IOP at each timepoint

**Time Frame:** 28 days of dosing

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Inglewood

**Country:** United States

**Facility:** United Medical Research Institute

**State:** California

**Zip:** 90301

**Location 2:**

**City:** Petaluma

**Country:** United States

**Facility:** North Bay Eye Associates

**State:** California

**Zip:** 94954

**Location 3:**

**City:** Poway

**Country:** United States

**Facility:** Centre For Health Care

**State:** California

**Zip:** 92064

**Location 4:**

**City:** Stuart

**Country:** United States

**Facility:** East Florida Eye Institute

**State:** Florida

**Zip:** 34994

**Location 5:**

**City:** Tamarac

**Country:** United States

**Facility:** Marvin Greenberg, MD

**State:** Florida

**Zip:** 33321

**Location 6:**

**City:** Roswell

**Country:** United States

**Facility:** Coastal Research Associates, LLC

**State:** Georgia

**Zip:** 30076

**Location 7:**

**City:** Shawnee Mission

**Country:** United States

**Facility:** Bradley Kwapiszeski, MD

**State:** Kansas

**Zip:** 66204

**Location 8:**

**City:** Louisville

**Country:** United States

**Facility:** Taustine Eye Center

**State:** Kentucky

**Zip:** 40217

**Location 9:**

**City:** St Louis

**Country:** United States

**Facility:** Comprehensive Eye Care

**State:** Missouri

**Zip:** 63090

**Location 10:**

**City:** New York

**Country:** United States

**Facility:** Mount Sinai School Of Medicine

**State:** New York

**Zip:** 10029

**Location 11:**

**City:** Rochester

**Country:** United States

**Facility:** Rochester Ophthalmology Group

**State:** New York

**Zip:** 14618

**Location 12:**

**City:** Slingerlands

**Country:** United States

**Facility:** Glaucoma Consultants of the Capital Region

**State:** New York

**Zip:** 12159

**Location 13:**

**City:** Charlotte

**Country:** United States

**Facility:** Charlotte Eye Ear Nose and Throat

**State:** North Carolina

**Zip:** 28210

**Location 14:**

**City:** Tulsa

**Country:** United States

**Facility:** The Eye Institute

**State:** Oklahoma

**Zip:** 74104

**Location 15:**

**City:** Rapid City

**Country:** United States

**Facility:** Black Hills Regional Eye Institute

**State:** South Dakota

**Zip:** 57701

**Location 16:**

**City:** Maryville

**Country:** United States

**Facility:** Univ Eye Surgeons, Maryville Ctr.

**State:** Tennessee

**Zip:** 37803

**Location 17:**

**City:** Austin

**Country:** United States

**Facility:** Texan Eye

**State:** Texas

**Zip:** 78731

**Location 18:**

**City:** San Antonio

**Country:** United States

**Facility:** Medical Center Ophth. Associates

**State:** Texas

**Zip:** 78731

#### Overall Officials

**Official 1:**

**Affiliation:** Aerie Pharmaceuticals, Inc.

**Name:** Thomas van Haarlem, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M9013

- Name: Glaucoma

- Relevance: HIGH

- As Found: Glaucoma

- ID: M12731

- Name: Ocular Hypertension

- Relevance: HIGH

- As Found: Elevated Intraocular Pressure

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005901

- Term: Glaucoma

- ID: D000009798

- Term: Ocular Hypertension

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnAg

- Name: Antihypertensive Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: HIGH

- As Found: Procedure

- ID: M12814

- Name: Ophthalmic Solutions

- Relevance: HIGH

- As Found: Start

- ID: M1775

- Name: Latanoprost

- Relevance: HIGH

- As Found: Brain Stimulation

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019999

- Term: Pharmaceutical Solutions

- ID: D000077338

- Term: Latanoprost

- ID: D000009883

- Term: Ophthalmic Solutions

### Misc Info Module

- Version Holder: 2024-05-24
