Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost

NCT ID: NCT06883123

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2026-04-01

Brief Summary

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.

Conditions

Open Angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Simbrinza and Rocklatan

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

Group Type: EXPERIMENTAL

Simbrinza 0.2%-1% Ophthalmic Suspension

Intervention Type: DRUG

brinzolamide and brimonidine tartrate

Rocklatan 0.02%-0.005% Ophthalmic Solution

Intervention Type: DRUG

netarsudil and latanoprost

Cosopt and Latanoprost

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

Group Type: ACTIVE_COMPARATOR

Cosopt PF 2%-0.5% Ophthalmic Solution

Intervention Type: DRUG

dorzolamide hydrochloride and timolol maleate

Latanoprost 0.005% Ophthalmic Solution

Intervention Type: DRUG

Latanoprost

Interventions

Simbrinza 0.2%-1% Ophthalmic Suspension

brinzolamide and brimonidine tartrate

Intervention Type: DRUG

Rocklatan 0.02%-0.005% Ophthalmic Solution

netarsudil and latanoprost

Intervention Type: DRUG

Cosopt PF 2%-0.5% Ophthalmic Solution

dorzolamide hydrochloride and timolol maleate

Intervention Type: DRUG

Latanoprost 0.005% Ophthalmic Solution

Latanoprost

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Prairie Eye Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

Prairie Eye Center

Locations

Prairie Eye Center

Springfield, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Lyons

Role: CONTACT

jenniferlyons37@gmail.com

217-257-3102

Facility Contacts

Jennifer Lyons

Role: primary

jenniferlyons37@gmail.com

217-257-3102

Other Identifiers

SY-25-01

Identifier Type: -

Identifier Source: org_study_id