NCT00473304

Contact Lens in Pediatrics (CLIP) in an Asian Population Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Singapore National Eye Centre · Other Government
• Sex: All
• Age: 8 Years – 11 Years
• Healthy volunteers: Accepted

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 parent/patient 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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Johnson&Johnson Acuevue daily disposable lenses

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-05-15
• Last updated: 2010-05-12

Locations

1 site across 1 country: Singapore