Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction

NCT07082816 | Completed Phase 3 FDA Drug

• 1 other identifier: GLR749-C001
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 30

Brief Summary

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).

Conditions

Ocular Hypertension; Open Angle Glaucoma

Keywords

Glaucoma; OAG; OHT

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure at each timepoint post-randomization

  Intraocular pressure (IOP) will be measured with a Goldmann tonometer and recorded in millimeters mercury (mmHg). IOP will be calculated as the mean of two readings or the median of three readings at each timepoint.

  Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours

Secondary Outcomes (6)

• Proportion of subjects with moderate to severe conjunctival hyperemia as assessed by biomicroscopy

  Up to Month 3/study exit

• Proportion of subjects with conjunctival hyperemia adverse events

  Up to Month 3/study exit

• Mean change from diurnally adjusted baseline IOP at each timepoint post-randomization

  Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours

• Percent change from diurnally adjusted baseline IOP at each timepoint post-randomization

  Baseline (Day 1), Week 2, Week 6, Month 3 at 08:00, 10:00, 16:00 hours

• Mean TSS-IOP scores at Month 3

  Month 3

Study Arms (2)

Reformulated PG324

EXPERIMENTAL

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

Drug: Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution

PG324

ACTIVE COMPARATOR

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

Drug: Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution

Interventions

Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution DRUG

Investigational ophthalmic solution

Also known as: Reformulated PG324

Reformulated PG324

Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution DRUG

Commercially available ophthalmic solution

Also known as: PG324, Rocklatan®

PG324

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (30)

Trinity Research Group

Dothan, Alabama, 36301, United States

Location

Eye Doctors of Arizona

Phoenix, Arizona, 85028, United States

Location

Orange County Ophthalmology Medical Group

Garden Grove, California, 92843, United States

Location

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Sacramento Eye Consultants

Sacramento, California, 95815, United States

Location

Central Florida Eye Specialists

DeLand, Florida, 32720, United States

Location

Glaucoma Specialists of South Florida

Delray Beach, Florida, 33484, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32256, United States

Location

Central Florida Eye Associates

Lakeland, Florida, 33805, United States

Location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

Lee Shettle Eye

Largo, Florida, 33773, United States

Location

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

Location

Coastal Research Associates

Roswell, Georgia, 30076, United States

Location

Kannarr Eye Care LLC

Pittsburg, Kansas, 66762, United States

Location

NorthEast Eye Research Associates, LLC

Westborough, Massachusetts, 01581, United States

Location

Coldwater Vision Research

Coldwater, Mississippi, 38618, United States

Location

Las Vegas Eye Institute

Henderson, Nevada, 89052, United States

Location

Rochester Ophthalmological Group

Rochester, New York, 14618, United States

Location

Albemarle Eye Center

Elizabeth City, North Carolina, 27909, United States

Location

Oculus Research, Inc.

Garner, North Carolina, 27529, United States

Location

CORE, Inc.

Shelby, North Carolina, 28150, United States

Location

Midwest Eye Center

Cincinnati, Ohio, 45236, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle; Glaucoma

Interventions

netarsudil; Latanoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Clinical Trial Lead, Pharma

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start: September 2, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)