Evaluate the Efficacy and Safety of CTO0307 in Adults With Presbyopia

Inclusion criteria

• Men and women aged ≥40 years and <65 years.
• Patients who meet all of the following visual acuity assessment criteria:

① DCNVA between 20/100 and 20/40 (Snellen equivalent) at screening and randomization.

② CDVA of 20/25 or better (Snellen equivalent) at screening and randomization.

③ high-contrast, near visual acuity in each eye of 20/40 or better (Snellen equivalent) with near correction, and a refractive error in each eye between spherical -4.00D to +2.00D and cylinder -2.00D to +2.00D after best distance correction at screening.

④ high-contrast, binocular distance visual acuity of 20/32 or better (Snellen equivalent) while wearing the patient's existing unifocal glasses (or uncorrected if not previously corrected with glasses or other corrective devices) at screening; or patients who agree to wear new unifocal corrective glasses to maintain a photopic, high-contrast, binocular CDVA of 20/32 or better during the study period.

• Patients who are capable of performing all study procedures, including questionnaires and examinations, and willing to cooperate with the investigator's instructions.
• Patients who voluntarily provided written informed consent, or whose legally authorized representative provided written informed consent, to participate in this clinical trial.

Exclusion criteria

• Patients with a history of ophthalmic surgery that may affect the absorption, distribution, or excretion of the investigational product, including cataract surgery, phakic intraocular lens (IOL) surgery, corneal inlay surgery, radial keratotomy (RK), or other intraocular surgeries.
• Patients with a history of LASIK, LASEK, or PRK (Photorefractive Keratectomy) within one year prior to screening.
• Patients with hyperopia exceeding +2.0D who do not usually wear spectacles.
• Patients with a history of hypersensitivity to the components of the investigational product or other cholinergic agonist drugs.
• Patients with the following conditions known to require cautious administration of the investigational product components:

• Bronchial asthma, heart failure, Parkinson's disease.
• Gastrointestinal (GI) stenosis (e.g., intestinal obstruction), duodenal ulcer, GI spasms, or clinically significant defecation disorders due to constipation.
• Urinary tract obstruction due to urinary tract disorders.
• Myocardial infarction.
• Clinically significant arrhythmia.
• Hyperthyroidism.
• Patients who have received at least one dose of another investigational product within 30 days prior to participation in this clinical trial.
• Patients deemed inappropriate by the investigator due to other diseases or conditions that may affect the evaluation of the efficacy or safety of the clinical trial.