PresbyopiaPhase 3NCT07723716
Evaluate the Efficacy and Safety of CTO0307 in Adults With Presbyopia
A Phase 3 study testing CTO0307 Eye drop in people with Presbyopia, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- CTO0307 Eye drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2025to 25 Sep 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- ② CDVA of 20/25 or better (Snellen equivalent).
- 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.
Who cannot join
- 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 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.
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- Urinary tract obstruction due to urinary tract disorders.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-design, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CTO0307 in Adults With Presbyopia
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.
- Conditions
- Presbyopia
- Being tested
- CTO0307 Eye drop, Vehicle (Placebo solution)
- Keywords
- presbyopia
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO0307 Eye dropDrug
Pilocarpine ophthalmic solution, one drop in each eye, once daily, for up to 28 days
Vehicle (Placebo solution)Drug
Vehicle, one drop in each eye, once daily, for up to 28 days.
| Study group | Role | What they receive |
|---|---|---|
| CTO0307 | Experimental | CTO0307 Ophthalmic Solution Receives: Drug: CTO0307 Eye drop |
| Placebo | Placebo comparator | Vehicle Receives: Drug: Vehicle (Placebo solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 4
Secondary outcomes (3)
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
Measured: Week 4
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
Measured: Week 4
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.
- Very Much Improved
- Much Improved
- Minimally Improved
- No change
- Minimally Worse
- Much Worse
- Very Much Worse
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start26 Feb 2025
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taejoon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723716
- Sponsor's protocol ID
- CTO0307
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No