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

NCT00473304 | Completed

• 1 other identifier: R501/50/2006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Safety; Efficacy; Adaptation; myopia and contact lens wear in children

Outcome Measures

Primary Outcomes (1)

• 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

  December 2006 to July 2007

Secondary Outcomes (1)

• Questionaire filling by subject/parent

  Dec 2006 to July 2007

Interventions

Johnson&Johnson Acuevue daily disposable lenses DEVICE

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore

Location

Related Publications (3)

• 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. doi: 10.1016/S0161-6420(03)00795-4.

  PMID: 14644714 BACKGROUND

• 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.

  PMID: 11071345 BACKGROUND

• 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.

  PMID: 8906382 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Li Lim, FRCS(Ed)

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: December 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

SG (1)