36 Participants NeededMy employer runs this trial

Rocklatan for Glaucoma

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Eye Centers of Southeast Texas
Must be taking: Prostaglandin analogs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for certain types of glaucoma, an eye condition that can lead to vision loss. It compares two treatments: Rocklatan, a combination of two drugs, and latanoprost, a single drug. The trial aims to determine which treatment better reduces eye pressure. Suitable participants have mild to moderate open-angle glaucoma in both eyes and currently use three eye pressure-lowering medications, including a prostaglandin analog. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

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

Yes, participants must stop taking their current glaucoma medications for a washout period (time without taking certain medications) before the baseline visit.

What is the safety track record for these treatments?

Research has shown that Rocklatan, a combination of netarsudil and latanoprost, is generally safe for treating glaucoma. Studies have found that this combination effectively lowers eye pressure over a year.

In one study, 60% of patients reduced their eye pressure to 16 mm Hg or lower, demonstrating its effectiveness. Another study confirmed the drug's safety, with no serious side effects reported over a year.

Overall, Rocklatan is well-tolerated, with most patients not experiencing major side effects. This suggests it is a safe option for those considering joining a clinical trial with this treatment.12345

Why are researchers enthusiastic about this study treatment?

Rocklatan is unique because it combines two active ingredients: netarsudil and latanoprost. Most glaucoma treatments, like latanoprost, focus on lowering eye pressure by increasing the outflow of fluid. However, Rocklatan not only enhances fluid outflow but also reduces fluid production, offering a dual-action approach. Researchers are excited about Rocklatan because this combination could potentially improve eye pressure control more effectively than using latanoprost alone.

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

Research has shown that Rocklatan, a combination of netarsudil and latanoprost, effectively lowers eye pressure in people with glaucoma. This trial will compare Rocklatan with latanoprost alone. Rocklatan reduces eye pressure by 1.3 to 3.0 mm Hg more than using either netarsudil or latanoprost alone. In one study, 60% of patients using Rocklatan achieved an eye pressure of 16 mm Hg or lower, marking a significant improvement. Additionally, after 3 months, 43.5% of patients using Rocklatan reached an eye pressure of 15 mm Hg or less. These findings suggest that Rocklatan is a strong option for managing high eye pressure in glaucoma.13678

Who Is on the Research Team?

KT

Kevin Talbot, MD

Principal Investigator

Eye Centers of Southeast Texas

Are You a Good Fit for This Trial?

This trial is for adults (18+) with mild to moderate open-angle glaucoma in both eyes, good vision (20/60 or better), and currently using three eye pressure medications including a prostaglandin. People can't join if they have advanced glaucoma, recent laser treatment, certain eye conditions, allergies to study drugs, are pregnant/breastfeeding, or had prior glaucoma surgery.

Inclusion Criteria

Best-corrected visual acuity (BCVA) ≥20/60 in both eyes
Ability and willingness to provide informed consent
I am an adult with mild to moderate open-angle glaucoma in both eyes.
See 2 more

Exclusion Criteria

Known hypersensitivity to Rocklatan, latanoprost, or study medication components
Pregnancy or lactation
I have advanced glaucoma that threatens my central vision.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Day 0
1 visit (in-person)

DSLT Procedure

Direct Selective Laser Trabeculoplasty (DSLT) procedure is performed

Day 0
1 visit (in-person)

Washout Period

Participants undergo a washout period before baseline measurements

8 weeks

Baseline Visit

Baseline measurements are taken post washout

Week 8
1 visit (in-person)

Treatment

Participants receive either Rocklatan or Latanoprost treatment

4 weeks

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

  • Latanoprost
  • Rocklatan

Trial Overview

The study compares two treatments after a specific laser procedure for glaucoma: one eye gets Rocklatan (a combination of netarsudil and latanoprost drops) while the other gets just latanoprost drops. The goal is to see which lowers eye pressure more over about 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: RocklatanExperimental Treatment1 Intervention
Group II: LantanoprostActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eye Centers of Southeast Texas

Lead Sponsor

Sengi

Industry Sponsor

Trials
28
Recruited
2,100+

Citations

Efficacy and safety of netarsudil/latanoprost fixed-dose ... - PMC

Netarsudil/latanoprost FDC appears to be superior to netarsudil or latanoprost alone, with better ocular hypotensive effects.

One Year of Netarsudil and Latanoprost Fixed-Dose ...

A total of 515 patients experienced at least 1 AE: 82.8% (197/238) of patients in the netarsudil/latanoprost FDC group, 78.2% (190/243) in the netarsudil group, ...

Rocklatan Once-Daily Combo Eye Drop Shows Efficacy in ...

Results showed that Rocklatan reduced IOP 1.3-3.0 mm Hg more than netarsudil or latanoprost alone. In addition, a statistically significantly higher proportion ...

Fixed-combination glaucoma agent yields positive safety ...

In 60% of patients, the drug reduced the mean diurnal IOP to 16 mm Hg or lower-a significantly higher percentage than what was observed in the two comparator ...

NCT07465913 | Rocklatan vs Latanoprost Post-DSLT

This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser ...

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

The data contained in this submission establishes that administration of netarsudil ... safety of netarsudil/latanoprost over a 12-month period.

One Year of Netarsudil and Latanoprost Fixed-Dose ...

Ocular and systemic safety were evaluated up to month 12. Results: Netarsudil/latanoprost FDC maintained statistically superior IOP lowering ...

Study Details | NCT07325240 | 24-hour Effect of Rocklatan ...

The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost ...