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Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure

NCT02057575•Aerie Pharmaceuticals

View on ClinicalTrials.gov

Summary

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 years of age or greater.
•Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
•Corrected visual acuity in each eye equivalent to 20/200 or better
•Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria

•Ophthalmic:
•Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
•Intraocular pressure \>36 mmHg
•Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
•Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
•Refractive surgery in study eye(s)
•Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
•Evidence of ocular infection and inflammation
•Clinically significant ocular disease, 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 greater then 600 μm
+7 more criteria

Locations (23)

Kenneth Sall, M.D.

Artesia, California, United States

United Medical Research Institute

Inglewood, California, United States

Aesthetic Eye Care Institute

Newport Beach, California, United States

Bacharach practice

Petaluma, California, United States

Centre For Health Care

Poway, California, United States

Clayton Eye Center

Morrow, Georgia, United States

Coastal Research Associates, LLC

Roswell, Georgia, United States

Bradley Kwapiszeski, MD

Shawnee Mission, Kansas, United States

Taustine Eye Center

Louisville, Kentucky, United States

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, United States

Key Dates

Start Date

January 1, 2014

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2014

Last Updated

June 4, 2019

Enrollment

298

ACTUAL participants

Conditions

Open Angle GlaucomaOcular Hypertension

Interventions

PG324 Ophthalmic Solution 0.01%

DRUG

PG324 Ophthalmic Solution 0.02%

DRUG

Netarsudil (AR-13324) Ophthalmic Solution 0.02%

DRUG

Latanoprost Ophthalmic Solution 0.005%

DRUG

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

NCT07396441

Juvenile Open Angle GlaucomaDry Eye Disease (DED)+3 more

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RECRUITING

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: June 4, 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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Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

Inclusion Criteria

Exclusion Criteria

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