Rocklatan for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well a combination of eye drops, netarsudil and latanoprost, lowers eye pressure compared to latanoprost alone. It focuses on individuals with open-angle glaucoma or ocular hypertension, where high eye pressure can cause vision problems. Those with these conditions in both eyes who have had recent check-ups might be suitable candidates. The trial involves using one type of drop in each eye to determine which is more effective over 24 hours. Participants must follow specific study instructions and attend all visits. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications before joining the trial. Specifically, you cannot use more than two eye pressure-lowering medications within 30 days of screening, and some medications affecting eye pressure must be stopped according to a schedule. Other medications, like lubricating drops for dry eyes, can be used throughout the study.
What is the safety track record for these treatments?
A previous study found that combining netarsudil and latanoprost was as safe as using netarsudil alone over a year. Side effects were mostly mild and manageable. Most participants (89.1%) were satisfied with the treatment and would continue using it.
Latanoprost alone is widely used to treat glaucoma and high eye pressure. It is generally well-tolerated, with common side effects like mild eye redness or discomfort.
Overall, both treatment options have shown safety, with usually mild side effects. For any concerns, consult the study team or your eye care specialist.12345Why are researchers enthusiastic about this study treatment?
Rocklatan is unique because it combines two active ingredients, latanoprost and netarsudil, to tackle glaucoma in a novel way. Most treatments for glaucoma, like latanoprost alone, primarily work by increasing the outflow of fluid in the eye to lower intraocular pressure. However, Rocklatan adds netarsudil, which not only enhances fluid outflow but also reduces fluid production, offering a dual action. This combined approach could potentially improve pressure reduction more effectively than using either component alone, which is why researchers are eager to see its impact.
What is the effectiveness track record for Rocklatan in treating glaucoma?
Research has shown that the netarsudil-latanoprost combination, which participants in this trial may receive, effectively lowers eye pressure, a critical factor for people with glaucoma. Studies indicate that this combination reduces eye pressure more than latanoprost alone, another treatment arm in this trial, by an additional 1.3 to 3 mm Hg at various times. Lowering eye pressure is crucial because it helps prevent damage to the optic nerve. Additionally, patients tolerated the combination treatment well, making it a promising option for those with open-angle glaucoma or high eye pressure.26789
Who Is on the Research Team?
Arthur J Sit, MD, MS
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults at least 18 years old with open angle glaucoma or ocular hypertension. Participants will use the study medication in one eye and a comparison drug in the other eye nightly.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either netarsudil-latanoprost fixed combination or latanoprost alone for 14 consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Analysis
24-hour and diurnal IOP variability are analyzed over a period of 18 months
What Are the Treatments Tested in This Trial?
Interventions
- Latanoprost
- Netarsudil
Trial Overview
The trial tests the effectiveness of Rocklatan (a combination of netarsudil and latanoprost) against Latanoprost alone on reducing intraocular pressure over 24 hours in patients with glaucoma or ocular hypertension.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Alcon Research
Industry Sponsor
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
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 ...
24-hour Effect of Rocklatan Compared With Latanoprost in ...
The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared ...
Effectiveness and Tolerability of Netarsudil in Combination ...
A sustained ≥ 20% IOP reduction was observed in 16.2% of 123 eyes with at least 2 observations on treatment with netarsudil. Of the 138 subjects ...
Netarsudil, latanoprost fixed-dose combo outperforms ...
Outcomes. The combination therapy resulted in superior IOP reduction at all time points, lowering IOP by an additional 1.3 to 3 mm Hg compared ...
208259Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov
Integrated Assessment of Effectiveness. The data contained in this submission establishes the efficacy of netarsudil/latanoprost ophthalmic ...
Safety and efficacy of topically administered netarsudil ...
The purpose of our study was to compare safety and efficacy of topically administered 0.02% netarsudil − 0.005% latanoprost FDC with 0.005% latanoprost ...
NCT03284853 | Safety and Efficacy Study of PG324 ...
A Prospective, Double-masked, Randomized, Multicenter, Active-controlled, Parallel-group, 6-month Study Assessing the Safety and Ocular Hypotensive Efficacy ...
One Year of Netarsudil and Latanoprost Fixed-Dose ...
Netarsudil/latanoprost FDC demonstrated an ocular safety profile through month 12 that was similar to that of netarsudil alone. The most ...
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ophthalmologytimes.com
ophthalmologytimes.com/view/outcomes-and-impressions-of-netarsudil-latanoprost-fixed-dose-combination-therapy-after-switching-from-latanoprost-monotherapyOutcomes and impressions of netarsudil/latanoprost fixed ...
The authors commented, “Overall, 89.1% of participants reported a good or better satisfaction level, and 83.6% would consider continuing with ...
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