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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01789736
First received: February 9, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: PG286 Ophthalmic Solution 0.5%
Drug: AR-12286 Ophthalmic Solution 0.5%
Drug: Travoprost Ophthalmic Solution 0.004%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Assessing the Safety and Ocular Hypotensive Efficacy of PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components

Resource links provided by NLM:


Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:
  • Mean diurnal IOP [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the mean diurnal IOP across subjects within treatment group and time point at Day 28.


Secondary Outcome Measures:
  • IOP [ Time Frame: 7-28 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 234
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789736

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

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01789736     History of Changes
Other Study ID Numbers: PG286-CS202
Study First Received: February 9, 2013
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma
Ocular hypertension
AR-12286
Travoprost

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Travoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014