None listed
Conditions
Interventions
Drug : Patients with NTG(Normal Tension Glaucoma) were randomized and assigned the treatment schedule with XalostS or Vyzulta 0.024% administered as one drop daily for 12 weeks.
Experimental: XalostS
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 years or older. 2) Patients diagnosed with normal-tension glaucoma(intraocular pressure of 21 mmHg or less as measured using Goldmann applanation tonometry) 3) Patients who have anterior chamber angle grade = 2 (Shaffer scale) in each eye 4) those who completed the required waiting/washout period as of Visit 2 5) those who consented to participate in this clinical trial and voluntarily completed a written informed consent form(Informed Consent Form) prior to the start of the trial
Exclusion criteria
Exclusion criteria: 1) Primary angle-closure glaucoma, congenital glaucoma, or secondary glaucoma 2) Patients with a history of Acute Angle-closure Glaucoma 3) Those with uncorrected visual acuity or binocular corrected visual acuity of 20/80 or lower(logMAR 0.6) based on the Snellen visual acuity chart 4) Patients with intraocular inflammation such as scleritis or uveitis, optic neuritis, anterior ischemic optic neuropathy, optic disc crystals (Drusen), proliferative diabetic retinopathy, macular disease, or other conditions that may affect the visual field measurement results 5) Patients with a history of herpetic keratitis 6) Patients with corneal conditions that may interfere with tonometry measurements, such as corneal ulceration 7) Patients with a central corneal thickness that is outside the range of 470 µm or more and 591 µm or less 8) Patients who have undergone lacrimal punctal occlusion surgery 9) Patients who intend to use the following prohibited drugs during the clinical trial period: ? Artificial tears (excluding Sodium Hyaluronate or Carboxymethylcellulose Sodium), medications expected to affect intraocular pressure, or systemic intraocular pressure-lowering agents (oral or intravenous Carbonic Anhydrase Inhibitor, oral glycerol, etc.) ? All ocular, periocular, inhaled, nasal, or systemic corticosteroids 10) Patients for whom the investigator determines that prostaglandin monotherapy is not sufficient in consideration of the optic nerve head or visual field condition 11) Patients with a history of bronchial asthma or reactive airway disease, including severe chronic obstructive pulmonary disease (chronic bronchitis, emphysema, etc.) 12) Patients with a history of significant ocular trauma or intraocular surgery within 6 months of Visit 1, or patients who have undergone any ophthalmic procedure, including intraocular laser surgery, within 3 months 13) Patients with a history of vision correction surgery (refractive surgery), such as photorefractive keratectomy (PRK) or laser-assisted in situ keratomileusis (LASIK), within 3 months of Visit 1 14) Patients with known risk factors for macular edema, such as aphakia 15) Contact lens users 16) Pregnant or lactating women or those planning to become pregnant during the clinical trial period 17) Those who are sensitive or allergic to latanoprostene bunod, latanoprost, benzalkonium chloride, or any component of the clinical trial drug 18) Those who have participated in another interventional clinical trial (including human application trials) within 1 month (30 days) of Visit 1, or who plan to participate in another interventional clinical trial (including human application trials) after the start of this clinical trial 19) Other individuals deemed unsuitable for clinical trial participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Intraocular pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Intraocular pressure;tolerability;Adverse Events | — |
Countries
Korea, Republic of
Contacts
Public ContactChan Yun Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed