Reformulated PG324 Ophthalmic Solution for Intraocular Pressure Reduction

Alcon

Status and phase: Enrolling; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution; Drug: Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT07082816

GLR749-C001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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470 participants in 2 patient groups

Reformulated PG324

Experimental group

Description:

One drop of netarsudil 0.01%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months

Treatment:

Drug: Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution

PG324

Active Comparator group

Description:

One drop of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution in each eye in the evening for three months

Treatment:

Drug: Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution