Kangbook Samsung Medical Center
Seoul, South Korea
NCT Number: NCT07723716
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.
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Notify Me40 year–65 year
All sexes
Interventional
Phase 3
Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
① DCNVA between 20/100 and 20/40 (Snellen equivalent).
② CDVA of 20/25 or better (Snellen equivalent).
Exclusion criteria
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.
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
Time frame: 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 (Mesopic & Photopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity) of >20/40 from Baseline
Time frame: 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.
Taejoon Pharmaceutical Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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