Pupillary Dilation Effect During Cycloplegic Refraction
Conditions
Keywords
pupillary dilation
Brief summary
This is a prospective randomized study compared with active control arm.
Detailed description
This is a prospective randomized study compared with active control arm. The investigators compare the pupil size in subject when 30 minutes after administering IP (CTO0303 or active control).
Interventions
DRUGCTO0303-A
eye drop, 1 drop 3 times (every 5 minutes) a day
DRUGCTO0303-B
eye drop, 1 drop 3 times (every 5 minutes) a day
DRUGCTO0303-C
eye drop, 1 drop 3 times (every 5 minutes) a day
Sponsors
Taejoon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Pediatric or adolescent subjects those who get a written consent both whom and their parents (or legally acceptable representative) * Pediatric or adolescent subjects aged 4 to 15 years old based on date of written consent
Exclusion criteria
* Subjects with a history of severe systemic reaction or increased sensitivity to atropine * Subjects with anterior segment disease that interferes with ophthalmological examination (ex. corneal scar, corneal opacity and others) * Subjects administered mydriatic medication within 14 days prior to administration of Investigational Product * Subjects with contact lens
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pupillary dilation effect at 30 minutes after administration | From enrollment to the end of treatment at 1 day. | The pupil size is measured using a pupillometer 30 minutes after IP administration |
Countries
South Korea
Contacts
Primary ContactSukyoung Kwon, MPH., PhD
Backup Contacthyejeong Paik, MD
Outcome results
None listed