None listed
Conditions
Interventions
Drug : This clinical trial is conducted with patients diagnosed with primary open-angle glaucoma, ocular hypertension, or normal-tension glaucoma who are currently using latanoprost eye drops, includi
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 to less than 80 years old. 2) Patients diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension who are currently using Latanoprost eye drops with preservatives as monotherapy and have been determined by the investigators to require additional intraocular pressure-lowering effects. Patients with POAG should have open angles on gonioscopy (anterior chamber angle grade = 2 on the Shaffer scale) and demonstrate retinal nerve fiber layer defects or glaucomatous optic disc changes (such as neuroretinal rim thinning, disc excavation, or disc hemorrhage). It is recommended to select patients with confirmed glaucomatous visual field defects using reliable visual field (VF) tests (with false-positive errors <15%, false-negative errors <15%, and fixation loss <20%). 3) Patients who have not used the preservative-free Tafluprost/timolol fixed-dose combination eye drops within 3 months prior to the date of consent. 4) Individuals who have provided written consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1) Glaucoma secondary to conditions such as pseudo-exfoliative glaucoma or pigment dispersion syndrome. 2) History of ocular surgery (including corneal refractive surgery such as LASIK, LASEK, or intraocular surgery) within 6 months prior to the date of consent. 3) Patients with significant refractive errors (outside of ±6.00 D sphere or 2.00 D cylinder). 4) Baseline intraocular pressure exceeding 35 mmHg. 5) Patients with severe visual field depression (MD = -20 dB and/or VFI = 40). 6) Individuals with corneal abnormalities that may interfere with Goldmann applanation tonometry. 7) Patients with iritis or uveitis, or a history thereof. 8) Individuals with active external ocular disease or infection, excluding dry eye syndrome. 9) Patients with macular edema, retinal detachment, diabetic retinopathy, or any progressive or worsened retinal disease, as well as those who have undergone refractive keratotomy or invasive glaucoma surgery including laser treatments. 10) Patients currently using systemic beta-blockers or calcium-channel blockers. 11) Individuals with ocular diseases other than initial cataracts (corrected visual acuity = 0.5), chronic autoimmune diseases, acute cardiovascular diseases, or a history thereof. 12) Patients with uncontrolled diabetes mellitus. 13) Patients with hypertension. - Patients with resting systolic blood pressure (resting SBP) between 90 and 139 mm Hg and resting diastolic blood pressure (resting DBP) = 89 mm Hg, who have been taking antihypertensive medication without changes in dosage or administration method within 6 months prior to the date of consent, can be included. 14) Patients who have used topical steroids within the past 4 weeks or systemic steroids (excluding local dermatological use) within the past 1 week. 15) Pregnant or lactating women or women with plans for pregnancy within 6 months after consent. 16) Patients with a history of ocular artery or vein occlusion, or conditions related to venous congestion (e.g., congestive heart failure). 17) Patients with bronchial asthma or a history thereof, bronchospasm, or significant chronic obstructive pulmonary disease. 18) Patients with uncontrolled congestive heart failure, sinus bradycardia, atrioventricular block (second or third degree), or cardiogenic shock. 19) Patients with a history of hypersensitivity to the ingredients of this product. 20) Patients currently using other glaucoma treatment eye drops in addition to monotherapy with latanoprost. 21) Other individuals deemed unsuitable for clinical trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP(Intraocular pressure) Variation | — |
Secondary
| Measure | Time frame |
|---|---|
| IOP(Intraocular pressure) Variation;Microvascular improvement Variation;Intraocular pressure in the control group of normal-tension glaucoma patients.;Intraocular pressure response rate (percentage of subjects with a decrease in intraocular pressure of 20% or more);Intraocular pressure changes between primary open-angle glaucoma and normal-tension glaucoma subtypes.;Microvascular changes between primary open-angle glaucoma and normal-tension glaucoma subtypes. | — |
Countries
Korea, Republic of
Contacts
Public ContactKyungrim Sung
Asan Medical Center
Outcome results
None listed