Evaluate the Efficacy and Safety of CTO0307 in Adults With Presbyopia

NCT07723716 | Completed Phase 3

• 1 other identifier: CTO0307
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

This study was to compare the presbyopia correction effect between the treatment group and the control group, evaluated by the proportion of patients who achieved an improvement of 3 lines or more in mesopic binocular DCNVA at 3 hours post-dose after 4 weeks of administration of the investigational product.

Conditions

Presbyopia

Keywords

presbyopia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Gaining 3 Lines or More in DCNVA

  The proportion of patients who achieved an improvement of ≥3 lines from baseline in DCNVA at post-dose

  Week 4

Secondary Outcomes (3)

• Percentage of Participants Gaining 2 Lines or More in DCNVA at Week 4

  Week 4

• Percentage of Participants with DCNVA of >20/40 at Week 4

  Week 4

• Percentage of Participants with improvement in Patient Global Impression of Change (PGIC) at Week 4.

  Week 4

Study Arms (2)

CTO0307

EXPERIMENTAL

Pilocarpine

Drug: CTO0307; Other: Placebo

Placebo

PLACEBO COMPARATOR

Drug: CTO0307; Other: Placebo

Interventions

CTO0307 DRUG

Pilocarpine Eye drop

CTO0307; Placebo

Placebo OTHER

Vehicle

CTO0307; Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taejoon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Kangbook Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: February 26, 2025
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)