Simbrinza + Rocklatan for Open-Angle Glaucoma

Recruiting in Palo Alto (17 mi)

Overseen bySandra Yeh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Prairie Eye Center

No Placebo Group

Prior Safety Data

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.

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

+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

+7 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Simbrinza and RocklatanExperimental Treatment2 Interventions

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

Group II: Cosopt and LatanoprostActive Control2 Interventions

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