A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety of AR-13324 Ophthalmic Solution, 0.02% QD & BID Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure

Aerie Pharmaceuticals1 site in 1 country93 target enrollmentSeptember 2014

InterventionsAR-13324 Ophthalmic Solution 0.02%Placebo AR-13324 Ophthalmic Solution 0.02% BID Timolol maleate Ophthalmic Solution 0.5% BID

DrugsAR-13324 Ophthalmic Solution 0.02%AR-13324 Ophthalmic Solution 0.02% BID Timolol maleate Ophthalmic Solution 0.5% BID

Overview

Phase: Phase 3
Intervention: AR-13324 Ophthalmic Solution 0.02%
Conditions: Ocular Hypertension
Sponsor: Aerie Pharmaceuticals
Enrollment: 93
Locations: 1
Primary Endpoint: Extent of Exposure
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

December 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aerie Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•19 years of age or greater.
•Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
•Unmedicated (post-washout) IOP (Intraocular Pressure) \>20 mm Hg and \< 27 mm Hg in the study eye at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP \> 17 mm Hg and \< 27 mm Hg at 10:00 and 16:00 hrs (in the same eye).
•Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS (Early Treatment Diabetic Retinopathy Study) in each eye (equivalent to 20/200).
•Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria

•Ophthalmic:
•Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
•Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
•Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or β-adrenoceptor antagonists.
•Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
•Refractive surgery in either eye (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (laser eye surgery), corneal cross-linking, etc.).
•Ocular trauma in either eye within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening.
•Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye.
•Ocular medication in either eye 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).
•Clinically significant ocular disease in either eye (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, severe visual field defect).