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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789736
• Other study ID #: PG286-CS202
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2013
• Last updated: February 17, 2014
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• PG286 Ophthalmic Solution 0.5%
PG286 Ophthalmic Solution
• AR-12286 Ophthalmic Solution 0.5%
AR-12286 Ophthalmic Solution 0.5%
• Travoprost Ophthalmic Solution 0.004%
Travoprost Ophthalmic Solution 0.004%

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No