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Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure

NCT02674854•Aerie Pharmaceuticals

View on ClinicalTrials.gov

Summary

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years of age or older (19 years of age or older in Canada)
•2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
•3. Unmedicated intraocular pressure \>20mmHg and \<36mmHg in both eyes at 2 qualification visits
•4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
•5. Able to give informed consent and follow study instructions

Exclusion Criteria

•Ophthalmic:
•1. Clinically significant ocular disease
•2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
•3. Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
•4. Known hypersensitivity to any component of the formulation or latanoprost
•5. Previous glaucoma surgery or refractive surgery
•6. Ocular trauma within 6 months prior to screening
•7. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
•8. Recent or current ocular infection or inflammation in either eye
•9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
+8 more criteria

Locations (1)

Aerie Pharmaceuticals

Bedminster, New Jersey, United States

Key Dates

Start Date

February 1, 2016

Primary Completion Date

March 1, 2017

Completion Date

March 1, 2017

Last Updated

May 21, 2019

Enrollment

750

ACTUAL participants

Conditions

Open-angle GlaucomaOcular Hypertension

Interventions

PG324 Ophthalmic Solution 0.02%/0.005%

DRUG

Netarsudil (AR-13324) ophthalmic solution 0.02%

DRUG

Latanoprost ophthalmic solution 0.005%

DRUG

DSLT for Reducing Medication in Glaucoma

NCT07390890

Primary Open Angle GlaucomaOcular Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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