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

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).

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.

Key Inclusion Criteria:

• Diagnosis of open-angle glaucoma or ocular hypertension in both eyes;
• Unmedicated intraocular pressure measurements in the study eye as specified in the protocol;
• Corrected distance visual acuity equal to or better than 20/100 in the study eye.

Key Exclusion Criteria:

• Current use of more than 2 ocular hypotensive medications within 30 days;
• Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening;
• 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).