NCT06441643

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	AR-17043 Ophthalmic Solution	Investigational monotherapy supplied in three concentration levels: low, medium, high
DRUG	PG043 Ophthalmic Solution	Investigational fixed dose combination supplied in two concentration levels: low and high
DRUG	Latanoprost 0.005% Ophthalmic Solution	Marketed monotherapy
DRUG	Netarsudil 0.02% Ophthalmic Solution	Marketed monotherapy
DRUG	Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution	Marketed fixed dose combination
DRUG	AR-17043 Vehicle	Placebo comparator

Timeline

• Start date: 2024-09-04
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2024-06-04
• Last updated: 2025-11-18

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study