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Compares treatment options for Open Angle Glaucoma
Official title Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost
ClinicalTrials.gov ID: NCT06883123
What this study is testing
What is Simbrinza 0.2%-1% Ophthalmic Suspension?
Simbrinza 0.2%-1% Ophthalmic Suspension is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for open angle glaucoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- 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
You likely can't join 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...
- Patients with known history or presence of uncontrolled systemic diseases including diseases that, in investigator's opinion, may make it unsafe or...
- Patients with known history or presence of significant ocular diseases including corneal diseases, dystrophies or abnormalities that would prevent...
- Patients with a history of uncontrolled IOP with the combination of either Rocklatan + Simbrinza or Cosopt + Latanoprost dual therapy.
See the full eligibility 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...
- 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
- 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...
- 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.
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Springfield, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Springfield, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.