Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473304
Status:
COMPLETED
Last Update Posted:
2010-05-12
First Post:
2007-05-14
Brief Title:
Contact Lens in Pediatrics CLIP in an Asian Population Study
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLIP
Brief Summary:
To evaluate the safety efficacy and physiological performance of daily disposable spherical and toric soft contact lenses in a vision-corrected population of children ages 8-11 years of age To evaluate the ability of the practitioner to fit these lenses and for the children to wear and manage these lenses
Detailed Description:
This is a bilateral open-label dispensing evaluation of two daily lens types Eligible subjects will wear the study lenses for 3-months daily wear 1-Day Acuvue will be worn by spherical subjects and 1-Day Acuvue for Astigmatism will be worn by astigmats
There is a total of 4 study visits baseline contact fitting and dispensing 1 week 1 month and 3 month follow-up Tests conducted include manifest refraction and over-refraction keratometry visual acuity ACA ratio lens fit assessment slit lamp biomicroscopy and parentpatient questionaires
Each child was provided with a supply of lenses to last until the next scheduled follow-up visit unit-dose rewetting drops for rinsing their lenses if necessary and a daily log to complete each day until the next follow-up visit
Informed consent was obtained from all subjects after the nature of the study had been fully explained The study gained approval from the Ethics Committee of the Singapore Eye Research Institute
There is a total of 4 study visits baseline contact fitting and dispensing 1 week 1 month and 3 month follow-up Tests conducted include manifest refraction and over-refraction keratometry visual acuity ACA ratio lens fit assessment slit lamp biomicroscopy and parentpatient questionaires
Each child was provided with a supply of lenses to last until the next scheduled follow-up visit unit-dose rewetting drops for rinsing their lenses if necessary and a daily log to complete each day until the next follow-up visit
Informed consent was obtained from all subjects after the nature of the study had been fully explained The study gained approval from the Ethics Committee of the Singapore Eye Research Institute
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None