A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

Exclusion Criteria

• •Those with MD(mean deviation of visual field) loss of -20dB or more on visual field test
• •Those who have undergone ocular laser surgery within 3 months of screening
• •Those whose maximum corrected visual acuity(BCVA) is less than 0.25
• •Those who have used systemic corticosteroids within 1 month of randomization
• •Those who have used corticosteroids administered locally to the eye or eyelid within 2 weeks of randomization
• •Those who received intraocular corticosteroids through intravitreal or sub-Tenon injection within 6 months of randomization
• •Patients with chronic, recurrent or severe inflammatory eye disease
• •Those who have been diagnosed and treated for an eye infection or eye inflammation other than simple conjunctivitis within 3 months of the screening visit (in the case of simple conjunctivitis, within 2 months of the screening visit)
• •Persons with a history of hypersensitivity to clinical investigational drugs of their components
• •Those who need to wear contact lenses on visit days and when administering clinical trial drugs
• •Women and men of childbearing age who plan to become pregnant or do not intend to use medically acceptable contraception during the clinical trial periode(however, women of childbearing age who have not undergone sterilization surgery may participate in the clinical trial only if they are tested for pregnancy and the results are negative. You must agree to participate and maintain effective contraception for the entire clinical trial period).
• •Currently pregnant or lactating
• •Those who have suffered eye trauma or surgery within 6 months of the screening visit
• •Those who are confirmed to have a positive HBsAg or HCV Ab test result at the time of screening(can be used if test results are within 6 months from the time of screening)
• •Any abnormality that precludes reliable IOP measurement (e.g. corneal opacity, nystagmus, congenital cataract, damage to photosensitive tissue cells, optic neve/optic center disease/ptosis, keratoconus, etc. that precludes IOP measruement)
• •Those who have a positive history of HIV Ab in the past or are confirmed to have a positive HIV Ab test result at the time of screening (can be used if the test result is within 6 months of the time of screening)
• •Patients with bronchial asthma or a history of reactive airway disease, including bronchospasm and severe chronic obstructive pulmonary disease
• •Patients with sinus bradycardia, 2nd or 3rd degree atrioventricular block, obvious heart failure, cardiogenic shock, sinus dysfunction syndrome, sinoatrial block
• •Those taking MAO inhibitors
• •People taking antidepressants that affect noradrenaline transmission (e.g. tricyclic antidepressants, mianserin)
• •People with untreated pheochromocytoma
• •Subjects who, in the opinion of the investigator, have other ocular pathology (severe dry eyes, etc.) that makes it impossible to administer the investigational drug
• •Patients with severe renal impairment (creatinine clearance\<30mL/min) or hyperchloremic acidossis
• •Persons who received other investigational drugs within 30 days of randomization
• •Other people deemed unsuitable for participation in this clinical trial according to the medical opinion of the investigator