ACTIVE_NOT_RECRUITING

Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase III, Prospective, Double-Masked, Randomized, Multi-Center, Active-Controlled, Parallel Group Comparison Study Assessing the Ocular Hypotensive Efficacy of Reformulated PG324 Ophthalmic Solution in Subjects With Elevated Intraocular Pressure

Quick Facts

Study Start:2025-09-02
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07082816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of open-angle glaucoma or ocular hypertension in both eyes;
  2. * Unmedicated intraocular pressure measurements in the study eye as specified in the protocol;
  3. * Corrected distance visual acuity equal to or better than 20/100 in the study eye.
  1. * Current use of more than 2 ocular hypotensive medications within 30 days;
  2. * Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening;
  3. * 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).

Contacts and Locations

Principal Investigator

Clinical Trial Lead, Pharma
STUDY_DIRECTOR
Alcon Research, LLC

Study Locations (Sites)

Trinity Research Group
Dothan, Alabama, 36301
United States
Eye Doctors of Arizona
Phoenix, Arizona, 85028
United States
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
United States
United Medical Research Institute
Inglewood, California, 90301
United States
Eye Research Foundation
Newport Beach, California, 92663
United States
North Bay Eye Associates
Petaluma, California, 94954
United States
Sacramento Eye Consultants
Sacramento, California, 95815
United States
Central Florida Eye Specialists
DeLand, Florida, 32720
United States
Glaucoma Specialists of South Florida
Delray Beach, Florida, 33484
United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32256
United States
Central Florida Eye Associates
Lakeland, Florida, 33805
United States
The Eye Institute of West Florida
Largo, Florida, 33770
United States
Lee Shettle Eye
Largo, Florida, 33773
United States
North Georgia Eye Associates
Gainesville, Georgia, 30501
United States
Coastal Research Associates
Roswell, Georgia, 30076
United States
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762
United States
NorthEast Eye Research Associates, LLC
Westborough, Massachusetts, 01581
United States
Coldwater Vision Research
Coldwater, Mississippi, 38618
United States
Las Vegas Eye Institute
Henderson, Nevada, 89052
United States
Rochester Ophthalmological Group
Rochester, New York, 14618
United States
Albemarle Eye Center
Elizabeth City, North Carolina, 27909
United States
Oculus Research, Inc.
Garner, North Carolina, 27529
United States
CORE, Inc.
Shelby, North Carolina, 28150
United States
Midwest Eye Center
Cincinnati, Ohio, 45236
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
United States
Southern College of Optometry
Memphis, Tennessee, 38104
United States
Total Eye Care, PA
Memphis, Tennessee, 38119
United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States

Collaborators and Investigators

Sponsor: Alcon Research

  • Clinical Trial Lead, Pharma, STUDY_DIRECTOR, Alcon Research, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-02
Study Completion Date2026-05

Study Record Updates

Study Start Date2025-09-02
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Glaucoma
  • OAG
  • OHT

Additional Relevant MeSH Terms

  • Ocular Hypertension
  • Open Angle Glaucoma