Rocklatan for Glaucoma

Overseen By Denzil Romfh, OD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must be taking: Latanoprost

Disqualifiers: Visual acuity, Age, Eye disease, others

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

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

Compensation: Varies

Number of Visits: 6

Duration: 11-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Rocklatan eye drops affect blood flow in the eyes of people with glaucoma, a condition that can lead to vision loss. Researchers aim to determine if special devices can detect changes in eye blood flow after using the drops. Participants should have glaucoma in both eyes and have been using latanoprost, a common glaucoma medication, but still experience high eye pressure affecting their daily life. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have been on latanoprost monotherapy (using only one medication) before joining. It's best to discuss with the trial team or your doctor.

What is the safety track record for Rocklatan?

Research has shown that Rocklatan, a combination of two medications, is generally safe for treating glaucoma. In studies, Rocklatan proved effective and safe over 12 months, with most side effects being mild. For instance, 59% of patients experienced some eye redness, but only 5% found it bothersome. The FDA has already approved this eye drop for open-angle glaucoma, indicating it has passed important safety tests. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Rocklatan is unique because it combines two active ingredients, netarsudil and latanoprost, which are both used to lower intraocular pressure in glaucoma patients. Most treatments for glaucoma typically involve using single-agent eye drops, such as prostaglandin analogs or beta-blockers. However, Rocklatan's dual-action formula not only reduces fluid production but also enhances fluid outflow, potentially offering more effective pressure reduction. Researchers are excited about Rocklatan because this combination may provide better control of eye pressure with a single drop, improving convenience and adherence for patients.

What is the effectiveness track record for Rocklatan in treating glaucoma?

Research shows that Rocklatan, which participants in this trial may receive, effectively lowers eye pressure, crucial for treating glaucoma. Studies have found that Rocklatan reduces eye pressure by 1 to 3 mmHg more than using either of its components, netarsudil or latanoprost, alone. This combination treatment is well-tolerated and provides a significant, lasting reduction in eye pressure. The fixed-dose combination of netarsudil and latanoprost in Rocklatan consistently yields better results in lowering eye pressure compared to using each component separately. Overall, Rocklatan has proven effective for managing the eye pressure associated with glaucoma. ^{1 6 7 8 9}

Who Is on the Research Team?

David Huang, MD, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for individuals with glaucoma in one eye. Participants will use Rocklatan eye drops nightly for up to a year. The study requires regular check-ups using OCT devices to monitor blood flow changes in the eye.

Inclusion Criteria

Abnormal VF (glaucomatous pattern with PSD abnormal at p<0.05 or GHT outside normal limits) on most recent two clinic visits on chart review

Overall average NFL thickness > 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma

Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph

Exclusion Criteria

Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit

OCT and OCTA scans not meeting quality criteria at baseline

Inability to commit to the study visits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rocklatan eye drops to study its effects on blood flow in the eye

11-12 months

Baseline, 6 months, and 11-12 month endpoint visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Optical Coherence Tomography (OCT)
• Rocklatan

Trial Overview The study tests how Rocklatan eye drops affect blood flow within the eye of glaucoma patients over 12 months. It also evaluates if OCT imaging can detect these blood flow changes effectively after treatment.

How Is the Trial Designed?

Group I: Eye with Diagnosed Glaucoma Experimental Treatment 2 Interventions

Group II: Control Eye Active Control 1 Intervention

This is also an eye with glaucoma, but the control eye will use clinically prescribed medication instead of the study drug.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Alcon Vision

Collaborator

Trials

1

Recruited

30+

Alcon Research

Industry 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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35904596/

The effectiveness and tolerability of fixed-dose combination ... Conclusion: FCNL was well-tolerated and demonstrated a significant and sustained reduction in IOP, even as last-line therapy before incisional ...

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. rocklatan.myalcon.com rocklatan.myalcon.com/ecp/efficacy/

Efficacy | ROCKLATAN® for ECPs The average IOP-lowering effect of ROCKLATAN® was 1 to 3 mmHg greater than monotherapy with either netarsudil 0.02% or latanoprost 0.005% throughout 12 months ...

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

208259Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov Integrated Assessment of Effectiveness. The data contained in this submission establishes the efficacy of netarsudil/latanoprost ophthalmic ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589419620301575

One Year of Netarsudil and Latanoprost Fixed-Dose ... Netarsudil/latanoprost FDC demonstrated statistically superior IOP lowering relative to its individual active components at all time points over 3 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9376331/

Efficacy and safety of netarsudil/latanoprost fixed-dose ... Netarsudil/latanoprost FDC appears to be superior to netarsudil or latanoprost alone, with better ocular hypotensive effects.

7. glaucoma.org glaucoma.org/articles/fda-approves-rocklatan-eye-drop-for-open-angle-glaucoma

FDA Approves Rocklatan Eye Drop For Open-Angle ... In these studies, Rocklatan achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, ...

8. investor.alcon.com investor.alcon.com/news-and-events/press-releases/news-details/2024/New-Data-at-ASCRS-Highlight-Alcon-Innovations-that-Optimize-Patient-Outcomes-/default.aspx

New Data at ASCRS Highlight Alcon Innovations that ... Hydrus Microstent remains the first and only minimally invasive glaucoma surgery (MIGS) device to report significant safety and effective ...

9. rocklatan.myalcon.com rocklatan.myalcon.com/ecp/safety-and-dosing/

Safety and Dosing | ROCKLATAN® for ECPs ROCK inhibitors may cause vasodilation on the ocular surface · 59% of patients experienced hyperemia in clinical studies; however, only 5% of patients ...