NCT02558374

Brief Summary

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
708

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 6, 2018

Completed
Last Updated

April 6, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

September 16, 2015

Results QC Date

January 17, 2018

Last Update Submit

March 9, 2018

Conditions

Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • IOP (Intraocular Pressure)

    The primary efficacy outcome is mean IOP

    3 months

Secondary Outcomes (1)

  • Extent of Exposure

    6 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 twice daily (BID) in the morning (AM) \& 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
Timolol Maleate Ophthalmic Solution 0.5% BIDDRUG

1 drop BID, AM/PM, OU

Timolol Maleate Ophthalmic Solution 0.5% BID
PlaceboOTHER

1 drop QD, AM, OU

AR-13324 Ophthalmic Solution 0.02% & placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Diagnosis of open angle glaucoma or ocular hypertension in both eyes
  • Post-washout intraocular pressure \>20mmHg and \<30mmHg in 1 or both eyes at 2 qualification visits
  • Corrected visual acuity equivalent to 20/200
  • Able to give informed consent and follow study instructions

You may not qualify if:

  • Clinically significant ocular disease
  • Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
  • Unmedicated intraocular pressure ≥30mmHg
  • Use of more than 2 ocular hypotensive medications within 30 days of screening
  • Known hypersensitivity to any component of the formulation
  • Previous glaucoma surgery or refractive surgery
  • Ocular trauma within 6 months prior to screening
  • Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
  • Recent or current ocular infection or inflammation in either eye
  • Used ocular medication in either eye of any kind within 30 days of screening
  • Mean central corneal thickness \>620µm at screening
  • Any abnormality preventing reliable applanation tonometry of either eye
  • Clinically significant abnormalities in lab tests at screening
  • Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
  • Clinically significant systemic disease
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aerie Pharmaceuticals

Bedminster, New Jersey, 07921, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

netarsudilBID protein, human

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Results Point of Contact

Title
Nancy Ramirez-Davis, Director of 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

September 16, 2015

First Posted

September 24, 2015

Study Start

September 1, 2015

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)