70 Participants Needed

Simbrinza + Rocklatan for Open-Angle Glaucoma

JL
Overseen ByJennifer Lyons
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Prairie Eye Center
Must be taking: Cosopt, Latanoprost
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 aims to explore how two medications, Simbrinza and Rocklatan, can help manage open-angle glaucoma, a common eye condition that can lead to vision loss. Researchers seek to determine if these drugs are more effective than the current standard treatment of Cosopt and Latanoprost. Individuals diagnosed with mild to moderate open-angle glaucoma who have used Cosopt and Latanoprost for at least a month might be suitable candidates for this trial. As a Phase 4 trial, this research helps to understand how these FDA-approved treatments can benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires participants to be on a combination of Cosopt and Latanoprost for at least 1 month before joining. It seems you may need to continue these medications during the trial.

What is the safety track record for Simbrinza and Rocklatan?

Research has shown that both Simbrinza and Rocklatan are generally safe for treating open-angle glaucoma. Studies have found that people with this eye condition usually tolerate these medications well. Simbrinza combines two drugs, brinzolamide and brimonidine tartrate, while Rocklatan contains netarsudil and latanoprost. Both effectively manage eye pressure.

Most people do well with these treatments, but some might experience mild side effects. For example, those with a history of eye inflammation should use Rocklatan with caution. Overall, both treatments are considered safe and have been used in glaucoma care for a long time.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Simbrinza and Rocklatan for treating open-angle glaucoma because these medications target the condition in a unique way. Simbrinza combines brinzolamide and brimonidine tartrate, which work together to reduce eye pressure by decreasing fluid production and increasing drainage. Rocklatan, on the other hand, combines netarsudil and latanoprost, enhancing fluid outflow through different pathways. This dual-action approach is different from standard treatments like Cosopt and Latanoprost, which primarily focus on one mechanism. By using multiple mechanisms to lower eye pressure, Simbrinza and Rocklatan could offer more effective management of glaucoma symptoms.

What evidence suggests that Simbrinza and Rocklatan might be an effective treatment for open-angle glaucoma?

This trial will compare the effectiveness of Simbrinza and Rocklatan with Cosopt and Latanoprost for treating open-angle glaucoma (OAG). Research has shown that Simbrinza and Rocklatan effectively lower intraocular pressure. Specifically, studies found that Rocklatan, a combination of netarsudil and latanoprost, often reduces eye pressure more effectively than each drug alone. Simbrinza, which contains brinzolamide and brimonidine, also lowers eye pressure. These medications benefit patients requiring multiple drugs to control eye pressure. Both treatments are well-regarded for managing glaucoma symptoms by employing different methods to effectively reduce eye pressure.25678

Who Is on the Research Team?

SY

Sandra Yeh, MD

Principal Investigator

Prairie Eye Center

Are You a Good Fit for This Trial?

Adults with mild to moderate open-angle glaucoma, who have been using Cosopt and Latanoprost for at least a month. Participants must have optic nerve damage, an intraocular pressure (IOP) between 18-28 mmHg, and corneal thickness of 450-650 µm. Excluded are those with recent eye surgeries or treatments, pregnant women, individuals on systemic medications affecting IOP, or with hypersensitivity to study drugs.

Inclusion Criteria

Evidence of optic nerve damage based on AAO Preferred Practice Patterns guidelines
Mean diurnal IOP ≥ 18 mmHg and < 28 mmHg at baseline in each eye with an inter-eye IOP difference < 5 mmHg
A central corneal thickness (CCT) within the range of 450-650 µm
See 1 more

Exclusion Criteria

I had glaucoma surgery or laser treatment over a year ago.
Subjects who are pregnant, lactating or planning a pregnancy
Any condition in the opinion of the investigator that would potentially confound the results of this study
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Simbrinza and Rocklatan or Cosopt and Latanoprost for glaucoma treatment

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Simbrinza and Rocklatan
Trial Overview The trial is testing the effectiveness of two different eye drop combinations: Simbrinza plus Rocklatan versus Cosopt plus Latanoprost in adults with open-angle glaucoma. It's a randomized study where patients are assigned by chance to one of these treatment groups.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Simbrinza and RocklatanExperimental Treatment2 Interventions
Group II: Cosopt and LatanoprostActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prairie Eye Center

Lead Sponsor

Trials
1
Recruited
70+

Sengi

Industry Sponsor

Trials
28
Recruited
2,100+

Citations

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.
Simbrinza + Rocklatan for Open-Angle GlaucomaTrial Overview The trial is testing the effectiveness of two different eye drop combinations: Simbrinza plus Rocklatan versus Cosopt plus Latanoprost in adults ...
Efficacy of Simbrinza and Rocklatan vs Cosopt and LatanoprostPatients with a history of uncontrolled IOP with the combination of either Rocklatan + Simbrinza or Cosopt + Latanoprost dual therapy.
Ophthalmics, Glaucoma Agents Therapeutic Class Review ...Brinzolamide (Azopt) and brinzolamide/brimonidine (Simbrinza) have not been studied in patients with acute angle-closure glaucoma. ...
208259Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.govIntegrated Assessment of Effectiveness. The data contained in this submission establishes the efficacy of netarsudil/latanoprost ophthalmic ...
Safety and Dosing | ROCKLATAN® for ECPsUse with caution in patients with a history of intraocular inflammation (iritis/uveitis). Should generally not be used in patients with active intraocular ...
Topical Medication Therapy for Glaucoma and Ocular ...The topical medical therapy is as the first line treatment in the management of glaucoma since it is inexpensive, convenient, effective, and safe.
Ophthalmic Agents, Intraocular Pressure (IOP)-ModifyingA network meta-analysis evaluated data from 28 randomized controlled trials in patients with primary open-angle glaucoma or ocular hypertension ...
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