Double-masked Study of AR-13324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT02207491 | Completed Phase 3 Results

• 1 other identifier: AR-13324-CS301
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the ocular hypotensive efficacy and ocular and systemic safety of AR-13324 Ophthalmic Solution, 0.02% compared to the active comparator Timolol maleate Ophthalmic Solution, 0.5%

Conditions

Ocular Hypertension; Open-angle Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  The primary efficacy outcome is mean IOP

  3 months

Secondary Outcomes (1)

• Extent of Exposure

  3 months

Study Arms (2)

AR-13324 Ophthalmic Solution 0.02% & Placebo

EXPERIMENTAL

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

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

Timolol maleate Ophthalmic Solution 0.5% BID

ACTIVE COMPARATOR

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

Drug: Timolol maleate Ophthalmic Solution 0.5% BID

Interventions

Timolol maleate Ophthalmic Solution 0.5% BID DRUG

1 drop BID, AM/PM, OU

Timolol maleate Ophthalmic Solution 0.5% BID

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

Placebo OTHER

1 drop QD, AM, OU

AR-13324 Ophthalmic Solution 0.02% & Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and 18 years or greater.
• Diagnosis of open angle glaucoma or ocular hypertension
• Unmedicated (post-washout) IOP (Intraocular Pressure) \>20 mm Hg and \< 27 mm Hg in the study eye at 2 qualification visits.
• Corrected visual acuity in each eye equivalent to 20/200.
• Able and willing to give signed informed consent (parent or guardian consent for pediatric patient) 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 beta adrenoceptor antagonists.
• Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye
• Refractive surgery in either eye.
• 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.
• 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.
• 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)

Aerie Pharmaceuticals

Bedminster, New Jersey, 07921, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle; Glaucoma

Interventions

BID protein, human; netarsudil

Condition Hierarchy (Ancestors)

Eye Diseases

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, Inc.

  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: July 31, 2014
• First Posted: August 4, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-01

Locations

US (1)