Presbyopia
Conditions
Keywords
presbyopia
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.
Interventions
DRUGCTO0307 Eye drop
Pilocarpine ophthalmic solution, one drop in each eye, once daily, for up to 28 days
Vehicle, one drop in each eye, once daily, for up to 28 days.
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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 informed consent, or whose legally authorized representative provided written informed consent, to participate in this clinical trial.
Exclusion criteria
1. 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. 2. Patients with a history of LASIK, LASEK, or PRK (Photorefractive Keratectomy) within one year prior to screening. 3. Patients with a history of hypersensitivity 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 clinically significant 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Gaining 3 Lines or More in DCNVA | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Gaining 2 Lines or More in DCNVA at Week 4 | 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 |
| Percentage of Participants with DCNVA of >20/40 at Week 4 | Week 4 | Percentage of Participants with DCNVA (Mesopic \& Photopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity) of \>20/40 from Baseline |
| Percentage of Participants with improvement in Patient Global Impression of Change (PGIC) at Week 4. | 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 |
Countries
South Korea
Outcome results
None listed