Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost

Efficacy and Tolerability of Simbrinza and Rocklatan vs. Cosopt

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.

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Drug: Simbrinza 0.2%-1% Ophthalmic Suspension; Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution; Drug: Cosopt PF 2%-0.5% Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jennifer Lyons; Phone Number: 217-257-3102; Email: jenniferlyons37@gmail.com

Study Locations

• United States
  • Illinois
    • Springfield, Illinois, United States, 62704
      • Recruiting
      • Prairie Eye Center
      • Contact: Jennifer Lyons; Phone Number: 217-257-3102; Email: jenniferlyons37@gmail.com
      • Principal Investigator: Sanda Yeh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Adults aged Eighteen (18) years and older 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. Evidence of optic nerve damage will be based on AAO Preferred Practice Patterns guidelines using either or both of the following:
• Optic disc or retinal nerve fiber layer (RNFL) structural abnormalities
• Diffuse or focal narrowing, or notching, of the optic disc rim, especially at the inferior or superior poles, which forms the basis for the ISNT rule
• Progressive narrowing of the neuroretinal rim with an associated increase in cupping of the optic disc
• Diffuse or localized abnormalities of the parapapillary RNFL, especially at the inferior or superior poles
• Disc rim, parapapillary RNFL, or lamina cribrosa hemorrhages
• Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
• Large extent of parapapillary atrophy
• Reliable and reproducible visual field abnormality considered a valid representation of the subject's functional status
• Visual field damage consistent with RNFL damage (e.g. nasal step, arcuate field defect, or paracentral depression in clusters of test sites)
• Visual field loss across the horizontal midline in one hemifield that exceeds loss in the opposite hemifield (in early/ moderate cases)
• Absence of other known explanations (e.g. optic disc drusen, optic nerve pit)
• Mean diurnal IOP ≥ 18 mmHg and < 28 mmHg at baseline in at least one eye with an inter-eye IOP difference < 5 mmHg.
• A central corneal thickness (CCT) within the range of 450-650 µm

Exclusion criteria:

• Patients with prior ocular procedures or intraocular surgery within 1 year prior to baseline (e.g. cataract surgery).
• Patients with prior history of glaucoma surgeries or laser treatment except patients with history of SLT >1 yr prior to baseline.
• Contraindications or known hypersensitivity to any or all the study medications including Rocklatan, Simbrinza, Cosopt and Latanoprost or related class of drugs.
• Patients with known history or presence of uncontrolled systemic diseases including diseases that, in investigator's opinion, may make it unsafe or undesirable for the subject to participate in the study and/ or limit adherence.
• Patients with known history or presence of significant ocular diseases including corneal diseases, dystrophies or abnormalities that would prevent accurate IOP readings with GAT.
• Patients with a history of uncontrolled IOP with the combination of either Rocklatan + Simbrinza or Cosopt + Latanoprost dual therapy.
• Significant ocular surface findings (e.g. hyperemia, irritation) found during slit lamp examination that might affect the study.
• Chronic use of any systemic medication for chronic diseases that may affect IOP.
• Subjects who are pregnant, lactating or planning a pregnancy.
• Any condition in the opinion in the investigator that would potentially confound the results of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simbrinza and Rocklatan; SIMBRINZA (brinzolamide and brimonidine tartrate) 1%/0.2% ROCKLATAN (netarsudil and latanoprost) 0.02%/0.005%	Drug: Simbrinza 0.2%-1% Ophthalmic Suspension; brinzolamide and brimonidine tartrate; Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution; netarsudil and latanoprost
Active Comparator: Cosopt and Latanoprost; COSOPT (dorzolamide hydrochloride and timolol maleate) 2%/0.5% Latanoprost 0.005%	Drug: Cosopt PF 2%-0.5% Ophthalmic Solution; dorzolamide hydrochloride and timolol maleate; Drug: Latanoprost 0.005% Ophthalmic Solution; Latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in mean diurnal IOP	Mean diurnal IOP is determined as the average IOP measured at 8:30am, 12:00pm and 3:30pm	from baseline at week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean decrease in IOP at 8:30am	from baseline at week 8
Mean decrease in IOP at 12:00pm	from baseline at week 8
Mean decrease in IOP at 4:30pm	from baseline at week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean % IOP diurnal reduction	Determined as the percentage decrease in average IOP measured at 8:30am, 12:00pm and 3:30pm	from baseline at week 8

Collaborators and Investigators

• Sponsor: Prairie Eye Center
• Collaborators: Sengi
• Investigators: Principal Investigator: Sandra Yeh, MD, Prairie Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Latanoprost; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: SY-25-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes