AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure

Phase 2

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: 0.5% AR-12286, 0.004% travoprost; Drug: 0.25% AR-12286 / 0.004% travoprost; Drug: 0.004% Travoprost

• Registration Number: NCT01474135
• Lead Sponsor: Aerie Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-11
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-18
• Study Start: 2011-12
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Disposition First Submitted: 2014-02-17
• Disposition First Submitted QC: 2014-03-25
• Disposition First Posted: 2014-04-21
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5% AR-12286/ 0.004% travoprost	0.5% AR-12286, 0.004% travoprost	Fixed dose combination of 0.5% AR-12286/ 0.004% travoprost
0.25% AR-12286/ 0.004% travoprost	0.25% AR-12286 / 0.004% travoprost	Fixed dose combination of 0.25% AR-12286 and 0.004% travoprost
0.004%Travoprost	0.004% Travoprost	Travatan(R) Z(travoprost ophthalmic solution)

Primary Outcome Measures

Name	Time	Method
Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.	7 days	Intraocular pressure

Secondary Outcome Measures

Name	Time	Method
Ocular and systemic safety	7 days	Ophthalmic examination and adverse event reports

Trial Locations

Locations (9)

Comprehensive Eye Care; 🇺🇸 St Louis, Missouri, United States

Bacharach practice; 🇺🇸 Petaluma, California, United States

Centre For Health Care; 🇺🇸 Poway, California, United States

Glaucoma Consultants of the Capital Region; 🇺🇸 Slingerlands, New York, United States

Aesthetic Eye Care Institute; 🇺🇸 Newport Beach, California, United States

Abrams Eye Center; 🇺🇸 Cleveland, Ohio, United States

Cataract & Glaucoma Center; 🇺🇸 El Paso, Texas, United States

Rochester Ophthalmology Group; 🇺🇸 Rochester, New York, United States

United Medical Research Institute; 🇺🇸 Inglewood, California, United States