AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474135
• Other study ID #: PG286-CS201
• Status: Completed
• Phase: Phase 2
• First received: November 11, 2011
• Last updated: April 18, 2014
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: April 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• 0.25% AR-12286 / 0.004% travoprost

• 0.5% AR-12286, 0.004% travoprost

• 0.004% Travoprost

Locations

Country	Name	City	State
United States	Abrams Eye Center	Cleveland	Ohio
United States	Cataract & Glaucoma Center	El Paso	Texas
United States	United Medical Research Institute	Inglewood	California
United States	Aesthetic Eye Care Institute	Newport Beach	California
United States	Bacharach practice	Petaluma	California
United States	Centre For Health Care	Poway	California
United States	Rochester Ophthalmology Group	Rochester	New York
United States	Glaucoma Consultants of the Capital Region	Slingerlands	New York
United States	Comprehensive Eye Care	St Louis	Missouri

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 IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.	Intraocular pressure	7 days	No
Secondary	Ocular and systemic safety	Ophthalmic examination and adverse event reports	7 days	Yes