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

A Study Assessing the Safety and Ocular Hypotensive Efficacy of PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: PG286 Ophthalmic Solution 0.5%; Drug: AR-12286 Ophthalmic Solution 0.5%; Drug: Travoprost Ophthalmic Solution 0.004%

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Kenneth Sall, M.D.
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Newport Beach, California, United States, 92657
      • Aesthetic Eye Care Institute
    • Petaluma, California, United States, 94954
      • Bacharach practice
    • Poway, California, United States, 92064
      • Centre For Health Care
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Bradley Kwapiszeski, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Alan L Robin, M.D.
    • Havre de Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Michigan
    • St Joseph, Michigan, United States, 49085
      • Great Lakes Eye Care
  • New York
    • Bronx, New York, United States, 10467
      • Jeffrey Schultz, M.D.
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group
  • North Carolina
    • Belmont, North Carolina, United States, 28012
      • Charlotte Eye Ear Nose & Throat Associates, P.A.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • The Eye Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye
    • San Antonio, Texas, United States, 78731
      • Medical Center Ophth. Associates
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Stacy R. Smith, M.D.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Subject 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.

Subject 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PG286; PG286 Ophthalmic Solution q.d. O.U.	Drug: PG286 Ophthalmic Solution 0.5%; PG286 Ophthalmic Solution
Experimental: AR-12286 Ophthalmic Solution 0.5%; AR-12286 Ophthalmic Solution 0.5% q.d. O.U.	Drug: AR-12286 Ophthalmic Solution 0.5%; AR-12286 Ophthalmic Solution 0.5%
Active Comparator: Travoprost 0.004%; Travoprost 0.004% q.d. O.U.	Drug: Travoprost Ophthalmic Solution 0.004%; Travoprost Ophthalmic Solution 0.004%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean diurnal IOP	The primary efficacy endpoint will be the mean diurnal IOP across subjects within treatment group and time point at Day 28.	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	Secondary efficacy endpoints will include: mean IOP across subjects within treatment group at each post-treatment timepoint, mean change from diurnally adjusted baseline IOP at each timepoint, mean percent change from diurnally adjusted baseline IOP at each timepoint, mean diurnal IOP at other visits, and mean change from the baseline mean diurnal IOP at each visits.	7-28 days

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 9, 2013
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Estimate): March 17, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Ocular hypertension; Glaucoma; Travoprost; AR-12286
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: PG286-CS202