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Tracking Information | |||||
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First Received Date † | May 14, 2007 | ||||
Last Updated Date | May 14, 2007 | ||||
Start Date † | December 2006 | ||||
Current Primary Outcome Measures † |
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 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
Questionaire filling by subject/parent [ Time Frame: Dec 2006 to July 2007 ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Contact Lens in Pediatrics (CLIP) in an Asian Population Study | ||||
Official Title † | |||||
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. |
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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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Myopia | ||||
Intervention † | Device: Johnson&Johnson Acuevue daily disposable lenses | ||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Estimated Enrollment † | 60 | ||||
Estimated Completion Date | July 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 8 Years to 11 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Singapore | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00473304 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Singapore National Eye Centre | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Singapore National Eye Centre | ||||
Verification Date | May 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |