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Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT02558400 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 718

Last updated 2019-06-04

Study results available
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Summary

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.

Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.

Conditions

Interventions

DRUG

PG324 Ophthalmic Solution 0.02%/0.005%

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

DRUG

Netarsudil (AR-13324) Ophthalmic Solution 0.02%

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

DRUG

Latanoprost Ophthalmic Solution 0.005%

1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Sponsors & Collaborators

  • Aerie Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Theresa Heah, MD, MBA · Aerie Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-18
Primary Completion
2017-05-17
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02558400 on ClinicalTrials.gov