Clinical trial NCT01474135: AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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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Primary outcomes:
measure: Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.
timeFrame: 7 days
Secondary outcomes:
measure: Ocular and systemic safety
timeFrame: 7 days
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Newport Beach
country: United States
facility: Aesthetic Eye Care Institute
state: California
city: Petaluma
country: United States
facility: Bacharach practice
state: California
city: Poway
country: United States
facility: Centre For Health Care
state: California
city: St Louis
country: United States
facility: Comprehensive Eye Care
state: Missouri
city: Rochester
country: United States
facility: Rochester Ophthalmology Group
state: New York
city: Slingerlands
country: United States
facility: Glaucoma Consultants of the Capital Region
state: New York
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: El Paso
country: United States
facility: Cataract & Glaucoma Center
state: Texas
Study officials:
References: