Phase
Condition
Glaucoma
Open Angle Glaucoma
Treatment
Simbrinza 0.2%-1% Ophthalmic Suspension
Latanoprost 0.005% Ophthalmic Solution
Cosopt PF 2%-0.5% Ophthalmic Solution
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Adults aged Eighteen (18) years and older with a diagnosis of mild to moderateopen-angle glaucoma (OAG), currently on an on-label use of combination topicalmedication of Cosopt and Latanoprost for a minimum of 1 month. Evidence of opticnerve damage will be based on AAO Preferred Practice Patterns guidelines usingeither 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 theinferior or superior poles, which forms the basis for the ISNT rule
Progressive narrowing of the neuroretinal rim with an associated increase in cuppingof the optic disc
Diffuse or localized abnormalities of the parapapillary RNFL, especially at theinferior or superior poles
Disc rim, parapapillary RNFL, or lamina cribrosa hemorrhages
Optic disc neural rim asymmetry of the two eyes consistent with loss of neuraltissue
Large extent of parapapillary atrophy
Reliable and reproducible visual field abnormality considered a valid representationof the subject's functional status
Visual field damage consistent with RNFL damage (e.g. nasal step, arcuate fielddefect, or paracentral depression in clusters of test sites)
Visual field loss across the horizontal midline in one hemifield that exceeds lossin 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 aninter-eye IOP difference < 5 mmHg.
A central corneal thickness (CCT) within the range of 450-650 µm
Exclusion
Exclusion criteria:
Patients with prior ocular procedures or intraocular surgery within 1 year prior tobaseline (e.g. cataract surgery).
Patients with prior history of glaucoma surgeries or laser treatment except patientswith history of SLT >1 yr prior to baseline.
Contraindications or known hypersensitivity to any or all the study medicationsincluding Rocklatan, Simbrinza, Cosopt and Latanoprost or related class of drugs.
Patients with known history or presence of uncontrolled systemic diseases includingdiseases that, in investigator's opinion, may make it unsafe or undesirable for thesubject to participate in the study and/ or limit adherence.
Patients with known history or presence of significant ocular diseases includingcorneal diseases, dystrophies or abnormalities that would prevent accurate IOPreadings 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 slitlamp 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 theresults of this study
Study Design
Connect with a study center
Prairie Eye Center
Springfield, Illinois 62704
United StatesActive - Recruiting
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