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CompletedNCT07723716Updated Aug 28, 2026

Evaluate the Efficacy and Safety of CTO0307 in Adults With Presbyopia

A Phase 3 interventional study of CTO0307 Eye drop and Vehicle (Placebo solution) in Presbyopia, sponsored by Taejoon Pharmaceutical Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Taejoon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Feb 2025, registered Jul 2026).
Phase
Phase 3
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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 post-dose after 4 weeks of administration of the investigational product.

02

Conditions studied

  • Presbyopia

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Keywords

  • presbyopia
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 167 is above the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Taejoon Pharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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

    ② CDVA of 20/25 or better (Snellen equivalent).

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of ophthalmic surgery that may affect the absorption, distribution, or excretion of the product, including cataract surgery, phakic intraocular lens (IOL) surgery, corneal inlay surgery, radial keratotomy (RK), or other intraocular surgeries.
  2. Patients with a history of LASIK, LASEK, or PRK (Photorefractive Keratectomy) within one year prior to screening.
  3. Patients with a history of to the components of the investigational product or other cholinergic agonist drugs.
  4. 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 defecation disorders due to constipation.
    • Urinary tract obstruction due to urinary tract disorders.
  5. Patients who have received at least one dose of another investigational product within 30 days prior to participation in this clinical trial.
  6. 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    CTO0307

    CTO0307 Ophthalmic Solution

    Drug: CTO0307 Eye drop

  • Placebo comparator
    Placebo

    Vehicle

    Drug: Vehicle (Placebo solution)

Interventions

  • DrugCTO0307 Eye drop

    Pilocarpine ophthalmic solution, one drop in each eye, once daily, for up to 28 days

  • DrugVehicle (Placebo solution)

    Vehicle, one drop in each eye, once daily, for up to 28 days.

06

What researchers measure

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 (Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity) at post-dose

    Time frame: Week 4

Secondary outcomes

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

    The proportion of patients who achieved an improvement of ≥2 lines from baseline in DCNVA (Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity) at post-dose

    Time frame: Week 4

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

    Percentage of Participants with DCNVA (Mesopic \& Photopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity) of \>20/40 from Baseline

    Time frame: Week 4

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

    Patients assessed the impact of the IP on near vision improvement using the PGIC scale. After the investigator explained the assessment method, patients performed the evaluation independently based on their own judgment. 1. Very Much Improved 2. Much Improved 3. Minimally Improved 4. No change 5. Minimally Worse 6. Much Worse 7. Very Much Worse

    Time frame: Week 4

07

Study locations

1 site
  • Kangbook Samsung Medical Center
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07723716
Responsible party
Sponsor
First posted
Jul 23, 2026
Start date
Feb 26, 2025
Primary completion
Sep 25, 2025
Completion
Sep 25, 2025
Last update
Aug 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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