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

NCT02246764 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2018-04-06

Study results available
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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

Interventions

DRUG

AR-13324 Ophthalmic Solution 0.02%

1 drop once daily (QD), PM, OU

DRUG

AR-13324 Ophthalmic Solution 0.02% BID

1 drop BID, AM/PM, OU

DRUG

Timolol maleate Ophthalmic Solution 0.5% BID

1 drop BID, AM/PM, OU

OTHER

Placebo

1 drop QD, AM, OU

Sponsors & Collaborators

  • Aerie Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Theresa Heah, MD · Aerie Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246764 on ClinicalTrials.gov