Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT02246764 | Completed Phase 3 Results

• 1 other identifier: AR-13324-CS303
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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%.

Conditions

Ocular Hypertension; Glaucoma

Keywords

Ocular hypertension.; Glaucoma

Outcome Measures

Primary Outcomes (1)

• Extent of Exposure

  Exposure to study medication in days for all treatment groups

  12 months

Study Arms (3)

AR-13324 Ophthalmic Solution 0.02% & placebo

EXPERIMENTAL

1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU)

Drug: AR-13324 Ophthalmic Solution 0.02%; Other: Placebo

AR-13324 Ophthalmic Solution 0.02% BID

EXPERIMENTAL

1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)

Drug: AR-13324 Ophthalmic Solution 0.02% BID

Timolol maleate Ophthalmic Solution 0.5% BID

ACTIVE COMPARATOR

1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)

Drug: Timolol maleate Ophthalmic Solution 0.5% BID

Interventions

AR-13324 Ophthalmic Solution 0.02% DRUG

1 drop once daily (QD), PM, OU

Also known as: Netarsudil

AR-13324 Ophthalmic Solution 0.02% & placebo

AR-13324 Ophthalmic Solution 0.02% BID DRUG

1 drop BID, AM/PM, OU

Also known as: Netarsudil

AR-13324 Ophthalmic Solution 0.02% BID

Timolol maleate Ophthalmic Solution 0.5% BID DRUG

1 drop BID, AM/PM, OU

Timolol maleate Ophthalmic Solution 0.5% BID

Placebo OTHER

1 drop QD, AM, OU

AR-13324 Ophthalmic Solution 0.02% & placebo

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Central corneal thickness in either eye greater than 600 µm at screening.
• Any abnormality in either eye preventing reliable applanation tonometry of either eye.
• Systemic:
• Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study.
• Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes).

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (1)

Nancy Ramirez

Bedminster, New Jersey, 07921, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

netarsudil; BID protein, human

Condition Hierarchy (Ancestors)

Eye Diseases

Limitations and Caveats

Enrollment was discontinued after 93 participants were enrolled due to slow enrollment; all participants who entered the study were followed until study completion.

Results Point of Contact

• Title: Nancy Ramirez-Davis, Director Clinical Project Management
• Organization: Aerie Pharmaceuticals, Inc.

nramirez@aeriepharma.com

908-947-3543

Study Officials

• Theresa Heah, MD

  Aerie Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 23, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 6, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-01

Locations

US (1)