A Study Assessing PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components for 28 Days

NCT ID: NCT01789736

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-06-30

Brief Summary

In the double-masked, randomized, multi-center, active-controlled parallel study, patients will be randomized to receive either a fixed dose combination of AR-12286 and travoprost, AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment arm.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PG286

PG286 Ophthalmic Solution q.d. O.U.

Group Type: EXPERIMENTAL

PG286 Ophthalmic Solution 0.5%

Intervention Type: DRUG

PG286 Ophthalmic Solution

AR-12286 Ophthalmic Solution 0.5%

AR-12286 Ophthalmic Solution 0.5% q.d. O.U.

Group Type: EXPERIMENTAL

AR-12286 Ophthalmic Solution 0.5%

Intervention Type: DRUG

AR-12286 Ophthalmic Solution 0.5%

Travoprost 0.004%

Travoprost 0.004% q.d. O.U.

Group Type: ACTIVE_COMPARATOR

Travoprost Ophthalmic Solution 0.004%

Intervention Type: DRUG

Travoprost Ophthalmic Solution 0.004%

Interventions

PG286 Ophthalmic Solution 0.5%

PG286 Ophthalmic Solution

Intervention Type: DRUG

AR-12286 Ophthalmic Solution 0.5%

AR-12286 Ophthalmic Solution 0.5%

Intervention Type: DRUG

Travoprost Ophthalmic Solution 0.004%

Travoprost Ophthalmic Solution 0.004%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or greater.

2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).

3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP >21 mmHg at 10:00 and 16:00 hrs.

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

Excluded from the study will be individuals with the following characteristics:

Ophthalmic (in either eye):

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.

2. Intraocular pressure > 35 mm Hg, or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.

3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, zinc, etc.), travoprost, 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 six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.

7. Evidence of ocular infection, inflammation, clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis at screening.

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

9. 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., 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 investigator) in laboratory tests at screening.

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

14. Participation in any investigational study within 30 days prior to screening.

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

16. 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 Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kenneth Sall, M.D.

Artesia, California, United States

United Medical Research Institute

Inglewood, California, United States

Aesthetic Eye Care Institute

Newport Beach, California, United States

Bacharach practice

Petaluma, California, United States

Centre For Health Care

Poway, California, United States

Clayton Eye Center

Morrow, Georgia, United States

Coastal Research Associates, LLC

Roswell, Georgia, United States

Bradley Kwapiszeski, MD

Shawnee Mission, Kansas, United States

Taustine Eye Center

Louisville, Kentucky, United States

Alan L Robin, M.D.

Baltimore, Maryland, United States

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, United States

Great Lakes Eye Care

Saint Joseph, Michigan, United States

Ophthalmic Consultants of Long Island

Lynbrook, New York, United States

Rochester Ophthalmological Group

Rochester, New York, United States

Jeffrey Schultz, M.D.

The Bronx, New York, United States

Charlotte Eye Ear Nose & Throat Associates, P.A.

Belmont, North Carolina, United States

The Eye Institute

Tulsa, Oklahoma, United States

Texan Eye

Austin, Texas, United States

Medical Center Ophth. Associates

San Antonio, Texas, United States

Stacy R. Smith, M.D.

Salt Lake City, Utah, United States

Virginia Eye Consultants

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

PG286-CS202

Identifier Type: -

Identifier Source: org_study_id