Next Generation Rocklatan

NCT06441643 | Completed Phase 2 FDA Drug

• 1 other identifier: GLR305-E001
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 12

Brief Summary

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).

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

Glaucoma; IOP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Mean IOP at each post-treatment timepoint (Stage 1)

  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)

  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)

  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)

  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)

  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)

Study Arms (10)

AR-17043 low concentration (Stage 1)

EXPERIMENTAL

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

AR-17043 medium concentration (Stage 1)

EXPERIMENTAL

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

AR-17043 high concentration (Stage 1)

EXPERIMENTAL

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

AR-17043 vehicle (Stage 1)

PLACEBO COMPARATOR

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

Rhopressa (Stage 1)

ACTIVE COMPARATOR

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

PG043 low concentration (Stage 2)

EXPERIMENTAL

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Drug: PG043 Ophthalmic Solution

PG043 high concentration (Stage 2)

EXPERIMENTAL

PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Drug: PG043 Ophthalmic Solution

AR-17043 high concentration (Stage 2)

ACTIVE COMPARATOR

AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Drug: AR-17043 Ophthalmic Solution

Latanoprost (Stage 2)

ACTIVE COMPARATOR

Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.

Drug: Latanoprost 0.005% Ophthalmic Solution

Rocklatan (Stage 2)

ACTIVE COMPARATOR

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

Interventions

AR-17043 Ophthalmic Solution DRUG

Investigational monotherapy supplied in three concentration levels: low, medium, high

AR-17043 high concentration (Stage 1); AR-17043 high concentration (Stage 2); AR-17043 low concentration (Stage 1); AR-17043 medium concentration (Stage 1)

PG043 Ophthalmic Solution DRUG

Investigational fixed dose combination supplied in two concentration levels: low and high

PG043 high concentration (Stage 2); PG043 low concentration (Stage 2)

Latanoprost 0.005% Ophthalmic Solution DRUG

Marketed monotherapy

Also known as: Latanoprost

Latanoprost (Stage 2)

Netarsudil 0.02% Ophthalmic Solution DRUG

Marketed monotherapy

Also known as: Rhopressa®

Rhopressa (Stage 1)

Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution DRUG

Marketed fixed dose combination

Also known as: Rocklatan®

Rocklatan (Stage 2)

AR-17043 Vehicle DRUG

Placebo comparator

AR-17043 vehicle (Stage 1)

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (12)

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

Eye Center of Northern Colorado, PC

Fort Collins, Colorado, 80528, United States

Location

Coastal Research Associates

Roswell, Georgia, 30076, United States

Location

Rochester Ophthalmological Group

Rochester, New York, 14618, United States

Location

James D. Branch Ophthalmology

Winston-Salem, North Carolina, 27101, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803, United States

Location

Total Eye Care PA

Memphis, Tennessee, 38119, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

Latanoprost; Ophthalmic Solutions; netarsudil

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: September 4, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)