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

Sponsor

Aerie Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01789736

Collaborator

(none)

234

Enrollment

Locations

Arms

3.9

Duration (Months)

11.1

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

Mean diurnal IOP [28 Days]
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 [7-28 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Subject inclusion criteria

18 years of age or greater.
Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
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.
Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
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):

Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
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.
Known hypersensitivity to any component of the formulation (benzalkonium chloride, zinc, etc.), travoprost, or to topical anesthetics.
Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
Evidence of ocular infection, inflammation, clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis at screening.
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).
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).
Central corneal thickness greater than 600 µm.
Any abnormality preventing reliable applanation tonometry of either eye.

Systemic:

Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
Participation in any investigational study within 30 days prior to screening.
Changes of systemic medication within 30 days prior to screening, or anticipated during the study, that could have a substantial effect on IOP.
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	Kenneth Sall, M.D.	Artesia	California	United States	90701
2	United Medical Research Institute	Inglewood	California	United States	90301
3	Aesthetic Eye Care Institute	Newport Beach	California	United States	92657
4	Bacharach practice	Petaluma	California	United States	94954
5	Centre For Health Care	Poway	California	United States	92064
6	Clayton Eye Center	Morrow	Georgia	United States	30260
7	Coastal Research Associates, LLC	Roswell	Georgia	United States	30076
8	Bradley Kwapiszeski, MD	Shawnee Mission	Kansas	United States	66204
9	Taustine Eye Center	Louisville	Kentucky	United States	40217
10	Alan L Robin, M.D.	Baltimore	Maryland	United States	21209
11	Seidenberg Protzko Eye Associates	Havre de Grace	Maryland	United States	21078
12	Great Lakes Eye Care	St Joseph	Michigan	United States	49085
13	Jeffrey Schultz, M.D.	Bronx	New York	United States	10467
14	Ophthalmic Consultants of Long Island	Lynbrook	New York	United States	11563
15	Rochester Ophthalmological Group	Rochester	New York	United States	14618
16	Charlotte Eye Ear Nose & Throat Associates, P.A.	Belmont	North Carolina	United States	28012
17	The Eye Institute	Tulsa	Oklahoma	United States	74104
18	Texan Eye	Austin	Texas	United States	78731
19	Medical Center Ophth. Associates	San Antonio	Texas	United States	78731
20	Stacy R. Smith, M.D.	Salt Lake City	Utah	United States	84117
21	Virginia Eye Consultants	Norfolk	Virginia	United States	23502