AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure

A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of Two AR 12286/Travoprost Fixed-dose Combination Products Compared to Travatan® Z in Patients With Elevated Intraocular Pressure

This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: 0.25% AR-12286 / 0.004% travoprost; Drug: 0.5% AR-12286, 0.004% travoprost; Drug: 0.004% Travoprost

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • 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
  • Missouri
    • St Louis, Missouri, United States, 63090
      • Comprehensive Eye Care
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmology Group
    • Slingerlands, New York, United States, 12159
      • Glaucoma Consultants of the Capital Region
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Texas
    • El Paso, Texas, United States, 79902
      • Cataract & Glaucoma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days apart. At second eligibility visit, IOP >22 mmHg at 10:00, 12:00 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:

Ophthalmic (in either eye):

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
2. Intraocular pressure > 36 mm Hg
3. Known hypersensitivity to travoprost, any component of the formulation (benzalkonium chloride, etc.), 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 past six months, or ocular surgery or laser treatment within the past three months.
7. History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
8. Contact lens wear within 30 minutes of instillation of study medication.
9. Ocular medication of any kind within 30 days of Visit 1, 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 Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
10. 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 (i.e., cup-disc ratio > 0.8).
11. Central corneal thickness greater than 600 µ.

12. Any abnormality preventing reliable applanation tonometry of either eye.

    Systemic:

13. Clinically significant abnormalities in laboratory tests at screening.
14. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
15. Participation in any investigational study within the past 30 days.
16. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.

17. Due to status of nonclinical safety program, 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.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.25% AR-12286/ 0.004% travoprost; Fixed dose combination of 0.25% AR-12286 and 0.004% travoprost	Drug: 0.25% AR-12286 / 0.004% travoprost
Experimental: 0.5% AR-12286/ 0.004% travoprost; Fixed dose combination of 0.5% AR-12286/ 0.004% travoprost	Drug: 0.5% AR-12286, 0.004% travoprost
Active Comparator: 0.004%Travoprost; Travatan(R) Z(travoprost ophthalmic solution)	Drug: 0.004% Travoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.	Intraocular pressure	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular and systemic safety	Ophthalmic examination and adverse event reports	7 days

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: November 11, 2011
• First Submitted That Met QC Criteria: November 17, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 12, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Antihypertensive Agents; Travoprost
• Other Study ID Numbers: PG286-CS201