NCT07723716CompletedPhase 3
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
Taejoon Pharmaceutical Co., Ltd.1 site in 1 country167 target enrollmentStarted: February 26, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 167
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Gaining 3 Lines or More in DCNVA
Study Overview
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 post-dose after 4 weeks of administration of the investigational product.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
- •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.
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 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.
- •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.
Arms & Interventions
Placebo
Placebo Comparator
Vehicle
Intervention: Vehicle (Placebo solution) (Drug)
CTO0307
Experimental
CTO0307 Ophthalmic Solution
Intervention: CTO0307 Eye drop (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Gaining 3 Lines or More in DCNVA
Time Frame: Week 4
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
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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