NCT06883123RecruitingPhase 4
Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost
Efficacy and Tolerability of Simbrinza and Rocklatan vs. Cosopt
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 12 Mar 2025
- Start date
- 14 May 2025
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Prairie Eye Center
- Diseases
- Glaucoma
- NCT number
- NCT06883123
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 70
- From 14 May 2025 to the primary completion date, 1 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Chronic use of any systemic medication for chronic diseases that may affect IOP.
- Any condition in the opinion in the investigator that would potentially confound the results of this study
Other
- Significant ocular surface findings (e.g. hyperemia, irritation) found during slit lamp examination that might affect the study.
- Subjects who are pregnant, lactating or planning a pregnancy.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prairie Eye Center Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.