None listed
Conditions
Interventions
Drug : Clinical investigational drugs are prescribed for subjects who meet the selection and exclusion criteria.
Drugs for clinical trial are disbursed to Visit 2 (Baseline) and Visit 3 (4 weeks), and
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults between 19 and 80 years of age 2) Patients diagnosed with primary open-angle glaucoma (POAG) for the first time Patients with primary open-angle glaucoma (POAG) have an open angle on gonioscopy (anterior chamber angle grade = 2 (Shaffer scale) in both eyes), retinal nerve fiber layer defects or glaucomatous optic disc changes (neuroretinal rim thinning, disc excavation, or disc hemorrhage). ) and one or more reliable visual field (VF) tests within 6 months (false-positive errors <15%, false negative errors <15%, and fixation loss <20%) confirmed glaucoma visual field defects 3) Those who have not been treated with glaucoma medications 4) Those with baseline intraocular pressure of 10 mmHg~34mmHg 5) Those who have agreed in writing to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Glaucoma caused by secondary causes such as pseudo-exfoliative glaucoma and pigment dispersion syndrome 2) Patients with severe visual field depression (MD = -20 dB and/or VFI = 40) 3) People with refractive error (outside of ± 6.00 D sphere or 2.00 D cylinder) 4) Those who have had eye surgery within 6 months from the date of consent 5) Those with a history of corneal refractive surgery including LASIK and LASEK 6) Those with corneal abnormalities that may interfere with Goldmann applanation tonometry examination 7) Patients with severe dry eye (those receiving or in need of drug treatment), active external eye disease, or ocular inflammatory diseases such as iritis or uveitis *In dry eye patients, only artificial tears are allowed. 8) Those with macular edema, retinal detachment, diabetic retinopathy, or retinal disease at risk of exacerbation 9) Hypertensive patients ? Those who have taken antihypertensive drugs within 6 months from the date of consent without any change in usage/dose and have a resting systolic blood pressure (resting SBP) of 90 to 139 mm Hg and diastolic blood pressure (resting DBP) = 89 mm Hg during screening are included. 10) Periocular trauma, surgical history, or thyroid orbitopathy affecting the evaluation of prostaglandin associated peri-orbitopathy 11) Those who are using systemic or eye drop steroids 12) Pregnant women, lactating women, or women who plan to become pregnant within 6 months of consent 13) Those who need to wear contact lenses during the clinical trial period 14) artificial lens eye (pseudophakia) or aphakic eye (aphakia) 15) Persons with a history of hypersensitivity to clinical investigational drugs 16) Other investigators who judged inappropriate to participate in clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of IOP | — |
Secondary
| Measure | Time frame |
|---|---|
| change of Microvascular improvement;Changes in intraocular pressure (IOP) in the normal-tension glaucoma (NTG) subgroup among all primary open-angle glaucoma (POAG); intraocular pressure (IOP) response rate;The number, expression rate and change of safety-related evaluation indicators | — |
Countries
Korea, Republic of
Contacts
Public ContactYoung Joo Song
Seoul National University Hospital
Outcome results
None listed