Status:
COMPLETED
Contact Lens in Pediatrics (CLIP) in an Asian Population Study
Lead Sponsor:
Singapore National Eye Centre
Conditions:
Myopia
Eligibility:
All Genders
8-11 years
Phase:
NA
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 evalu...
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...
Eligibility Criteria
Inclusion
- Be between 8-11 years of age.
- Signed Written Informed Consent and/or have the consent of a parent or legal guardian and Investigator to record this on Case Report Form (CRF) in appropriate space.
- Be a neophyte.
- Require a visual correction in both eyes.
- Require a soft contact lens spherical correction between +5.00 and -9.00 DS.
- Have an astigmatic correction between 0.00 amd 2.00 DC.
- Be able to wear the lens powers available for this study.
- Be correctable to a visual acuity of 20/25 or better in each eye.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- (i)No amblyopia. (ii) No evidence of lid abnormality or infection. (eg. entropion, ectropion, chalazia, recurrent styes). (iii) No clinically significant slit lamp (eg. any infiltrates or other slit lamp findings Grade 3 or above: corneal edema, corneal staining, tarsal abnormalities, conjunctival injection, vascularisation, or abnormal opacities).(iv) No other active ocular disease. (eg. glaucoma, history of recurrent corneal erosions, cornea infiltrates, conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
Exclusion
- Requires concurrent ocular medication.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- No clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Diabetic.
- Infectious disease (eg.hepatitis, tuberculosis)or an immunosuppressive disease (eg.HIV).
- PMMA or RGP lens wear in the previous 8 weeks.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- Abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment only.
- Participation in any concurrent clinical trial.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00473304
Start Date
December 1 2006
End Date
November 1 2008
Last Update
May 12 2010
Active Locations (1)
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1
Singapore National Eye Centre
Singapore, Singapore