Contact Lens in Pediatrics (CLIP) in an Asian Population Study (CLIP)
|ClinicalTrials.gov Identifier: NCT00473304|
Recruitment Status : Completed
First Posted : May 15, 2007
Last Update Posted : May 12, 2010
|Condition or disease||Intervention/treatment|
|Myopia||Device: Johnson&Johnson Acuevue daily disposable lenses|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2006|
|Primary Completion Date :||November 2008|
|Study Completion Date :||November 2008|
- i. demographics ii. refraction (D) visual acuity iii. AC/A Ratio (phorias in prism dioptres) iv. Keratometry v. Slit lamp examination vi. Corneal staining viii. Contact lens fit assessment [ Time Frame: December 2006 to July 2007 ]
- Questionaire filling by subject/parent [ Time Frame: Dec 2006 to July 2007 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473304
|Singapore National Eye Centre|
|Principal Investigator:||Li Lim, FRCS(Ed)||Singapore Eye Research Institute|