Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost

NCT06883123 | Recruiting Phase 4 FDA Drug

• 1 other identifier: SY-25-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (1)

• Mean % IOP diurnal reduction

  from baseline at week 8

Study Arms (2)

Simbrinza and Rocklatan

EXPERIMENTAL

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

Drug: Simbrinza 0.2%-1% Ophthalmic Suspension; Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution

Cosopt and Latanoprost

ACTIVE COMPARATOR

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

Drug: Cosopt PF 2%-0.5% Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

Simbrinza 0.2%-1% Ophthalmic Suspension DRUG

brinzolamide and brimonidine tartrate

Simbrinza and Rocklatan

Rocklatan 0.02%-0.005% Ophthalmic Solution DRUG

netarsudil and latanoprost

Simbrinza and Rocklatan

Cosopt PF 2%-0.5% Ophthalmic Solution DRUG

dorzolamide hydrochloride and timolol maleate

Cosopt and Latanoprost

Latanoprost 0.005% Ophthalmic Solution DRUG

Latanoprost

Cosopt and Latanoprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prairie Eye Center: lead
• Sengi: collaborator

Study Sites (1)

Prairie Eye Center

Springfield, Illinois, 62704, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

dorzolamide-timolol combination; Latanoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Sandra Yeh, MD

  Prairie Eye Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lyons

CONTACT

217-257-3102; jenniferlyons37@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: May 14, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)