Contact Lens in Pediatrics (CLIP) in an Asian Population Study - Full Text View

Sponsored by:	Singapore National Eye Centre
Information provided by:	Singapore National Eye Centre
ClinicalTrials.gov Identifier:	NCT00473304

Purpose

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.

Condition	Intervention
Myopia	Device: Johnson&Johnson Acuevue daily disposable lenses

MedlinePlus related topics: Children's Health Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Singapore National Eye Centre:

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 ]

Secondary Outcome Measures:

Questionaire filling by subject/parent [ Time Frame: Dec 2006 to July 2007 ]

Estimated Enrollment:	60
Study Start Date:	December 2006
Estimated Study Completion Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	8 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473304

Locations

Singapore
Singapore National Eye Centre
Singapore, Singapore

Sponsors and Collaborators

Singapore National Eye Centre

Investigators

Principal Investigator:

Li Lim, FRCS(Ed)

Singapore Eye Research Institute

More Information

Publications:

Sankaridurg PR, Sweeney DF, Holden BA, Naduvilath T, Velala I, Gora R, Krishnamachary M, Rao GN. Comparison of adverse events with daily disposable hydrogels and spectacle wear: results from a 12-month prospective clinical trial. Ophthalmology. 2003 Dec;110(12):2327-34.

Suchecki JK, Ehlers WH, Donshik PC. A comparison of contact lens-related complications in various daily wear modalities. CLAO J. 2000 Oct;26(4):204-13.

Solomon OD, Freeman MI, Boshnick EL, Cannon WM, Dubow BW, Kame RT, Lanier JC Jr, Lopanik RW, Quinn TG, Rigel LE, Sherrill DD, Stiegmeier MJ, Teiche RS, Zigler LG, Mertz GW, Nason RJ. A 3-year prospective study of the clinical performance of daily disposable contact lenses compared with frequent replacement and conventional daily wear contact lenses. CLAO J. 1996 Oct;22(4):250-7.

Study ID Numbers:	R501/50/2006
Study First Received:	May 14, 2007
Last Updated:	May 14, 2007
ClinicalTrials.gov Identifier:	NCT00473304
Health Authority:	Singapore: Singapore Eye Research Institute

Keywords provided by Singapore National Eye Centre:

Safety
Efficacy
Adaptation
myopia and contact lens wear in children

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 14, 2009