NCT06883123 Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost
| NCT ID | NCT06883123 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Prairie Eye Center |
| Condition | Open Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2025-05-14 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sandra Yeh, MD
PRINCIPAL INVESTIGATOR
Prairie Eye Center
Frequently Asked Questions
Who can join the NCT06883123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Open Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06883123 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06883123 currently recruiting?
Yes, NCT06883123 is actively recruiting participants. Contact the research team at jenniferlyons37@gmail.com for enrollment information.
Where is the NCT06883123 trial being conducted?
This trial is being conducted at Springfield, United States.
Who is sponsoring the NCT06883123 clinical trial?
NCT06883123 is sponsored by Prairie Eye Center. The principal investigator is Sandra Yeh, MD at Prairie Eye Center. The trial plans to enroll 70 participants.