Reformulated PG324 for Glaucoma

Recruiting at 29 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alcon Research

Must be taking: Ocular hypotensives

Must not be taking: Topical ocular medications

Disqualifiers: Intraocular pressure > 36 mmHg, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

470 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop, Reformulated PG324 Ophthalmic Solution, to determine if it safely and effectively lowers eye pressure in individuals with open-angle glaucoma (a common form of glaucoma) or ocular hypertension (high eye pressure without vision damage). Participants will apply the eye drop once daily in the evening for three months. The trial compares two different formulations to identify which is more effective. Ideal candidates have open-angle glaucoma or ocular hypertension in both eyes and have not recently used more than two eye pressure-lowering medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

You may need to stop using certain eye medications before joining the trial. Specifically, you can't use more than two eye pressure-lowering medications within 30 days before the trial, and you must stop using any eye medications at least 5 days before the trial, except for those that lower eye pressure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of netarsudil and latanoprost, which forms Reformulated PG324, is generally safe for individuals with open-angle glaucoma or high eye pressure. Studies have found that this combination effectively reduces eye pressure.

Most side effects are mild, such as eye redness or discomfort, and serious side effects are rare. This combination is already part of an FDA-approved treatment, indicating its safety for similar conditions. Although this trial tests a new version, existing evidence suggests these ingredients are safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Researchers are excited about the reformulated PG324 for glaucoma because it offers a potentially more effective way to lower eye pressure with a lower concentration of netarsudil. Most current treatments, like the standard PG324, use higher concentrations of netarsudil. However, this new formulation combines netarsudil 0.01% with latanoprost 0.005%, which might reduce side effects while maintaining effectiveness. By optimizing the balance of these active ingredients, this reformulation aims to enhance patient comfort and adherence to the treatment regimen.

What evidence suggests that Reformulated PG324 might be an effective treatment for glaucoma?

Research has shown that Reformulated PG324, a combination of netarsudil and latanoprost, effectively lowers eye pressure in individuals with open-angle glaucoma and ocular hypertension. These conditions result from increased pressure inside the eye due to fluid buildup. Studies have found that this combination reduces eye pressure more effectively than either drug alone. It facilitates fluid drainage from the eye, thereby lowering pressure. In this trial, participants will receive either the Reformulated PG324 or the PG324 formulation, both utilizing netarsudil and latanoprost together. Similar treatments have effectively managed eye pressure, suggesting that Reformulated PG324 could be highly effective in managing conditions like glaucoma by reducing eye pressure. ^{1 6 7 8 9}

Who Is on the Research Team?

Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for individuals with open-angle glaucoma or ocular hypertension. Participants should meet specific health criteria not detailed here.

Inclusion Criteria

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

I have been diagnosed with glaucoma or high eye pressure in both eyes.

Exclusion Criteria

Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening

I haven't used any eye drops except for pressure-lowering ones, which I've stopped.

I have used more than 2 eye pressure-lowering medications in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Reformulated PG324 or marketed PG324 eye drops for three months

12 weeks

Visits at Baseline (Day 1), Week 2, Week 6, and Month 3

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Reformulated PG324 Ophthalmic Solution

Trial Overview

The study tests a new eye drop, Reformulated PG324, in two strengths to see how well it lowers eye pressure in patients with OAG or OHT.

How Is the Trial Designed?

Group I: Reformulated PG324 Experimental Treatment 1 Intervention

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

Group II: PG324 Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

1.

trial.medpath.com

trial.medpath.com/clinical-trial/eb59a3f44d03f975/nct07082816-pg324-ophthalmic-solution-elevated-intraocular-pressure

Reformulated PG324 Ophthalmic Solution for Intraocular ...

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 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03284853

Safety and Efficacy Study of PG324 (Netarsudil ...

A Prospective, Double-masked, Randomized, Multicenter, Active-controlled, Parallel-group, 6-month Study Assessing the Safety and Ocular Hypotensive Efficacy ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11790064/

A Systematic Review and Network Meta-Analysis - PMC

In this study, the fixed-dose combination of AR-13324 0.02% and latanoprost 0.005% in PG324 Ophthalmic Solution provides clinically and ...

4.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2019/208259Orig1s000MedR.pdf

208259Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov

Primary Efficacy Endpoint. The primary efficacy outcome was the comparison of netarsudil/latanoprost ophthalmic solution relative to each of ...

5.

sigma.larvol.com

sigma.larvol.com/disease.php?e1=18856&e2=&DiseaseId=18856&tab=DiseaseOTT&sr=now&er=1+month&ipwnd=on&rlink=,DiseaseId=18856,tab=DiseaseOTT&rflag=1&page=2

Glaucoma Trials

2017-004524-29: This study will evaluate and confirm that the efficacy and tolerability of a new preservative-free generic formulation of Latanoprost l/Timolol ...

6.

mayoclinic.org

mayoclinic.org/drugs-supplements/netarsudil-and-latanoprost-ophthalmic-route/description/drg-20458422

Netarsudil and latanoprost (ophthalmic route) - Side effects ...

Netarsudil and latanoprost combination eye drops is used alone or together with other medicines to lower pressure inside the eye that is caused by open-angle ...

7.

rocklatan.myalcon.com

rocklatan.myalcon.com/

ROCKLATAN® Eye Drops | Patient Safety, Savings, Use ...

ROCKLATAN is a combination of 2 prescription medicines to reduce high eye pressure in patients with open-angle glaucoma or ocular hypertension.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31842637/

Netarsudil and latanoprost ophthalmic solution for the ...

This review aims to cover the agent's current efficacy and safety data and opine as to its role in glaucoma management.Areas covered: This article will cover ...

9.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2019/208259Orig1s000SumR.pdf

208259Orig1s000 SUMMARY REVIEW - accessdata.fda.gov

The safety database contained in this submission (including Studies PG324-CS301 and PG324. CS302 ) establishes the relative netarsudil and ...