Simbrinza + Rocklatan for Open-Angle Glaucoma

Overseen By Jennifer Lyons

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Prairie Eye Center

Must be taking: Cosopt, Latanoprost

Must not be taking: Rocklatan, Simbrinza

Disqualifiers: Ocular surgery, Uncontrolled diseases, 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: Unknown

Duration: 8 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized, multi-site, parallel-group, prospective study of patients who are adults with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month.

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 data supports the effectiveness of the drug Simbrinza + Rocklatan for treating open-angle glaucoma?

Research shows that ROCK inhibitors, like those in Rocklatan, effectively lower eye pressure by improving fluid drainage in the eye, which is crucial for treating glaucoma. Additionally, studies on similar drugs have shown significant reductions in eye pressure, suggesting potential benefits for this combination treatment. ^{1 2 3 4 5}

Is the combination of Simbrinza and Rocklatan safe for treating open-angle glaucoma?

Rho kinase inhibitors, like those in Rocklatan, have a good safety profile but can cause temporary side effects like eye redness and minor bleeding. These effects are usually mild and go away on their own. ^{1 6 7 8 9}

How is the drug Simbrinza + Rocklatan unique for treating open-angle glaucoma?

Simbrinza is a unique fixed-combination drug that combines two active ingredients, brinzolamide and brimonidine, to lower eye pressure in open-angle glaucoma without using timolol, which is common in other treatments. Rocklatan, which includes a Rho-associated kinase inhibitor, offers a novel mechanism to further reduce eye pressure, making this combination potentially more effective for patients needing multiple medications. ^{3 10 11 12 13}

Research Team

Sandra Yeh, MD

Principal Investigator

Prairie Eye Center

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Simbrinza and Rocklatan Experimental Treatment 2 Interventions

SIMBRINZA (brinzolamide and brimonidine tartrate) 1%/0.2% ROCKLATAN (netarsudil and latanoprost) 0.02%/0.005%

Group II: Cosopt and Latanoprost Active Control 2 Interventions

COSOPT (dorzolamide hydrochloride and timolol maleate) 2%/0.5% Latanoprost 0.005%

Who Is Running the Clinical Trial?

Prairie Eye Center

Lead Sponsor

Trials

1

Recruited

70+

Sengi

Industry Sponsor

Trials

28

Recruited

2,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Novel Pharmacologic Candidates for Treatment of Primary Open-Angle Glaucoma. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Investigational Rho Kinase Inhibitors for the Treatment of Glaucoma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Ocular Hypotensive Efficacy of Topical Fasudil, a Rho-Associated Protein Kinase Inhibitor, in Patients With End-Stage Glaucoma. [2018]

4. Croatia pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of mono-compound topical treatments for reduction of intraocular pressure in patients with primary open angle glaucoma or ocular hypertension: an overview of reviews. [2021]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Prostaglandin analogues in glaucoma treatment]. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Rho-Kinase Inhibitors as Emerging Targets for Glaucoma Therapy. [2023]

7. Romania pubmed.ncbi.nlm.nih.gov

[Travatan--preliminary results]. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

The Additive Effect of ROCK Inhibitor on Prostaglandin-Treated Japanese Patients with Glaucoma Indicating 15 mmHg and Under: ROCK U-15. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of latanoprost on primary open angle glaucoma: A protocol for a systematic review of randomized controlled trial. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Brinzolamide/brimonidine: a review of its use in patients with open-angle glaucoma or ocular hypertension. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Brinzolamide/Brimonidine Fixed Combination: Simplifying Glaucoma Treatment Regimens. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Fixed-combination and emerging glaucoma therapies. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Pharmaceutical approval update. [2021]