NCT07082816

Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

About 470 adults with OAG or OHT will be randomly divided into 2 groups. One group will use the new Reformulated PG324 eye drops, and the other group will use the marketed PG324 eye drops. This study will be double-masked, so neither the researcher nor the participant will know which eye drop was administered. The expected individual duration of participation is approximately 3 months.

Conditions

• Ocular Hypertension
• Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution	Investigational ophthalmic solution
DRUG	Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution	Commercially available ophthalmic solution

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-07-24
• Last updated: 2026-01-13

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study