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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
167
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.
Kangbook Samsung Medical Center
Seoul, South Korea
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
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
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
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
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