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Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction

NCT ID: NCT07082816

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2026-05-31

Brief Summary

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This study is designed to see how safe and effective a new eye drop, called Reformulated PG324, is for lowering eye pressure in people with open-angle glaucoma (OAG) or ocular hypertension (OHT).

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Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension

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Detailed Description

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About 470 adults with OAG or OHT will be randomly divided into 2 groups. One group will use the new Reformulated PG324 eye drops, and the other group will use the marketed PG324 eye drops. This study will be double-masked, so neither the researcher nor the participant will know which eye drop was administered. The expected individual duration of participation is approximately 3 months.

Conditions

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Ocular Hypertension Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reformulated PG324

One drop of netarsudil 0.01%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months

Group Type EXPERIMENTAL

Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution

Intervention Type DRUG

Investigational ophthalmic solution

PG324

One drop of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months

Group Type ACTIVE_COMPARATOR

Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution

Intervention Type DRUG

Commercially available ophthalmic solution

Interventions

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Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution

Investigational ophthalmic solution

Intervention Type DRUG

Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution

Commercially available ophthalmic solution

Intervention Type DRUG

Other Intervention Names

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Reformulated PG324 PG324 Rocklatan®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes;
* Unmedicated intraocular pressure measurements in the study eye as specified in the protocol;
* Corrected distance visual acuity equal to or better than 20/100 in the study eye.

Exclusion Criteria

* Current use of more than 2 ocular hypotensive medications within 30 days;
* Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening;
* Use of topical ocular medication of any kind within 5 days of Screening or throughout the study with the exception of ocular hypotensive medications (must be washed out).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, Pharma

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Trinity Research Group

Dothan, Alabama, United States

Site Status

Eye Doctors of Arizona

Phoenix, Arizona, United States

Site Status

Orange County Ophthalmology Medical Group

Garden Grove, California, United States

Site Status

United Medical Research Institute

Inglewood, California, United States

Site Status

Eye Research Foundation

Newport Beach, California, United States

Site Status

North Bay Eye Associates

Petaluma, California, United States

Site Status

Sacramento Eye Consultants

Sacramento, California, United States

Site Status

Central Florida Eye Specialists

DeLand, Florida, United States

Site Status

Glaucoma Specialists of South Florida

Delray Beach, Florida, United States

Site Status

East Coast Institute for Research, LLC

Jacksonville, Florida, United States

Site Status

Central Florida Eye Associates

Lakeland, Florida, United States

Site Status

The Eye Institute of West Florida

Largo, Florida, United States

Site Status

Lee Shettle Eye

Largo, Florida, United States

Site Status

North Georgia Eye Associates

Gainesville, Georgia, United States

Site Status

Coastal Research Associates

Roswell, Georgia, United States

Site Status

Kannarr Eye Care LLC

Pittsburg, Kansas, United States

Site Status

NorthEast Eye Research Associates, LLC

Westborough, Massachusetts, United States

Site Status

Coldwater Vision Research

Coldwater, Mississippi, United States

Site Status

Las Vegas Eye Institute

Henderson, Nevada, United States

Site Status

Rochester Ophthalmological Group

Rochester, New York, United States

Site Status

Albemarle Eye Center

Elizabeth City, North Carolina, United States

Site Status

Oculus Research, Inc.

Garner, North Carolina, United States

Site Status

CORE, Inc.

Shelby, North Carolina, United States

Site Status

Midwest Eye Center

Cincinnati, Ohio, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Site Status

Southern College of Optometry

Memphis, Tennessee, United States

Site Status

Total Eye Care, PA

Memphis, Tennessee, United States

Site Status

The Eye Institute of Utah

Salt Lake City, Utah, United States

Site Status

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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GLR749-C001

Identifier Type: -

Identifier Source: org_study_id

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