Rocklatan for Glaucoma

Overseen By Clinical Research Manager

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Center for Sight Las Vegas

Must not be taking: Steroids

Disqualifiers: Severe glaucoma, Retinal diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding a treatment called Rocklatan can further lower eye pressure in people with open-angle glaucoma, a condition that can lead to vision loss. Participants will receive either Rocklatan, which combines two medications, or a placebo to compare results. The trial is ideal for those who had cataract surgery and a Hydrus microstent implanted more than three months ago and have mild to moderate open-angle glaucoma. Participants should currently have eye pressure between 16-26 mmHg without medication or after stopping their current eye pressure medications. As a Phase 4 trial, Rocklatan is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

If you are currently on 0-2 types of eye pressure-lowering medications, you may need to stop them for a period (washout period) before joining the trial, but only if it's safe for you. The trial does not specify stopping other types of medications.

What is the safety track record for Rocklatan?

Research has shown that Rocklatan, a combination of netarsudil and latanoprost, is generally safe. Past studies revealed no new safety concerns, and importantly, no serious side effects were linked to the treatment. The most common side effect was mild eye redness. The FDA has already approved Rocklatan to lower eye pressure in individuals with glaucoma and high eye pressure, further supporting its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Rocklatan is unique because it combines netarsudil, a Rho kinase inhibitor, with latanoprost, a prostaglandin analogue, to tackle elevated intraocular pressure in glaucoma patients. While most treatments, like latanoprost or timolol, work by improving fluid outflow or reducing fluid production in the eye, Rocklatan works on multiple pathways to enhance efficacy. Researchers are excited because this dual-action approach may offer better pressure reduction and convenience compared to using two separate medications, potentially improving patient compliance and outcomes.

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

Research has shown that Rocklatan, a combination of netarsudil and latanoprost, effectively lowers high eye pressure in individuals with open-angle glaucoma or ocular hypertension. One study found that over 60% of patients using Rocklatan experienced a 30% or greater reduction in eye pressure, nearly double the reduction seen with latanoprost alone. This indicates that the combination works better than each medicine individually. The FDA has approved Rocklatan for these conditions, confirming its effectiveness. Participants in this trial will receive either Rocklatan or a placebo comparator, Systane artificial tears. These findings suggest that Rocklatan can significantly aid in managing glaucoma by reducing eye pressure. ^{2 3 6 7 8}

Who Is on the Research Team?

Medical Director, Medical Doctor

Principal Investigator

Center For Sight

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone Hydrus Microstent surgery to treat glaucoma and are looking for additional ways to lower their intraocular pressure. Specific eligibility criteria details were not provided.

Inclusion Criteria

Unmedicated or washed out IOP range between 16-26 mmHg

I have mild to moderate Open Angle Glaucoma.

I had cataract surgery with a Hydrus microstent over 3 months ago but less than 2 years ago.

Exclusion Criteria

Pregnant, breastfeeding or planning to become pregnant during the study

I have had or currently have an eye infection or inflammation.

I had laser eye surgery within the last 18 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rocklatan or placebo comparator for intraocular pressure reduction

4-5 weeks

Regular visits for intraocular pressure measurements

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rocklatan

Trial Overview The study aims to see if adding Rocklatan (a combination of netarsudil and latanoprost) after the Hydrus Microstent surgery can further reduce eye pressure in glaucoma patients, compared with a standard treatment using Systane.

How Is the Trial Designed?

Group I: FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) Active Control 1 Intervention

FDA approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Group II: Placebo Comparator Systane Artificial Tears Placebo Group 1 Intervention

Comparator arm is Systane artificial tears

Who Is Running the Clinical Trial?

Center for Sight Las Vegas

Lead Sponsor

Citations

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

Efficacy and safety of netarsudil/latanoprost fixed-dose ... The present study compared the efficacy and safety of netarsudil/latanoprost FDC with monotherapy of its individual components in patients with glaucoma.

2. ophthalmologyglaucoma.org ophthalmologyglaucoma.org/article/S2589-4196(20)30157-5/fulltext

One Year of Netarsudil and Latanoprost Fixed-Dose ... Results at 12 months revealed superior efficacy for netarsudil/latanoprost FDC compared with the individual components, netarsudil and ...

3. 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 ...

4. aao.org aao.org/headline/fda-approves-rocklatan-open-angle-glaucoma-ocular-

FDA approves Rocklatan for open-angle glaucoma, ocular ... More than 60% of patients taking Rocklatan achieved an IOP reduction of 30% or more, nearly twice that achieved by latanoprost alone.

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32166538/

Fixed-Dose Combination of Netarsudil and Latanoprost in ... Safety: No new safety signals were identified. Netarsudil/latanoprost FDC was associated with no treatment-related serious adverse events, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002939419302843

Netarsudil/Latanoprost Fixed-Dose Combination for ... In conclusion, treatment with once-daily netarsudil/latanoprost FDC provided clinically and statistically significantly greater IOP lowering over 3 months than ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35979215/

Efficacy and safety of netarsudil/latanoprost fixed-dose ... The present study compared the efficacy and safety of netarsudil/latanoprost FDC with monotherapy of its individual components in patients with glaucoma.