Next Generation Rocklatan

A Phase II, Prospective, Two-Stage, Double-Masked, Randomized, Multi-Center, Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 (AR-17043/Latanoprost) Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure

The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: AR-17043 Ophthalmic Solution; Drug: AR-17043 Vehicle; Drug: Netarsudil 0.02% Ophthalmic Solution; Drug: PG043 Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution; Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

Detailed Description

During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

• Study Type: Interventional
• Enrollment (Actual): 426
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92843
      • Orange County Ophthalmology Medical Group
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Eye Center of Northern Colorado, PC
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • James D. Branch Ophthalmology
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialists
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care PA
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Stage 1 Key Inclusion Criteria;

• Diagnosis of OAG or OHT in both eyes.
• High unmedicated IOP measurements in the study eye as specified in the protocol.
• Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
• Other protocol-specified inclusion criteria may apply.

Stage 2 Key Inclusion Criteria:

• Diagnosis of OAG or OHT in both eyes.
• High unmedicated IOP measurements in the study eye as specified in the protocol.
• Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
• Other protocol-specified inclusion criteria may apply.

Stage 1 and Stage 2 Key Exclusion Criteria:

• Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
• Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
• Glaucoma other than OAG.
• Previous glaucoma surgery.
• Any abnormality preventing reliable measurements.
• Unable to demonstrate proper eyedrop instillation.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR-17043 low concentration (Stage 1); AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.	Drug: AR-17043 Ophthalmic Solution; Investigational monotherapy supplied in three concentration levels: low, medium, high
Experimental: AR-17043 medium concentration (Stage 1); AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.	Drug: AR-17043 Ophthalmic Solution; Investigational monotherapy supplied in three concentration levels: low, medium, high
Experimental: AR-17043 high concentration (Stage 1); AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.	Drug: AR-17043 Ophthalmic Solution; Investigational monotherapy supplied in three concentration levels: low, medium, high
Placebo Comparator: AR-17043 vehicle (Stage 1); AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.	Drug: AR-17043 Vehicle; Placebo comparator
Active Comparator: Rhopressa (Stage 1); Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.	Drug: Netarsudil 0.02% Ophthalmic Solution; Marketed monotherapy; Other Names: Rhopressa®
Experimental: PG043 low concentration (Stage 2); PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.	Drug: PG043 Ophthalmic Solution; Investigational fixed dose combination supplied in two concentration levels: low and high
Experimental: PG043 high concentration (Stage 2); PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.	Drug: PG043 Ophthalmic Solution; Investigational fixed dose combination supplied in two concentration levels: low and high
Active Comparator: AR-17043 high concentration (Stage 2); AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.	Drug: AR-17043 Ophthalmic Solution; Investigational monotherapy supplied in three concentration levels: low, medium, high
Active Comparator: Latanoprost (Stage 2); Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.	Drug: Latanoprost 0.005% Ophthalmic Solution; Marketed monotherapy; Other Names: Latanoprost
Active Comparator: Rocklatan (Stage 2); Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.	Drug: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution; Marketed fixed dose combination; Other Names: Rocklatan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean diurnal IOP at Day 8 (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.	Day 8 (8:00, 10:00, 12:00, 16:00)
Mean diurnal IOP at Day 29 (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.	Day 29 (8:00, 10:00, 16:00)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.	Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00)
Mean IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.	Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2)	Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.	Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Pharma, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Actual): November 14, 2025
• Study Completion (Actual): November 14, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Glaucoma; IOP
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Pharmaceutical Solutions; Pharmaceutical Preparations; Fatty Acids; Lipids; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Biological Factors; Solutions; Specialty Uses of Chemicals; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Latanoprost; Ophthalmic Solutions; netarsudil
• Other Study ID Numbers: GLR305-E001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No