MyopiaCLIPNCT00473304
Contact Lens in Pediatrics (CLIP) in an Asian Population Study
A study testing Johnson&Johnson Acuevue daily disposable lenses in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Johnson&Johnson Acuevue daily disposable lenses
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2006to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- Johnson&Johnson Acuevue daily disposable lenses
- Keywords
- Safety, Efficacy, Adaptation, myopia and contact lens wear in children
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Johnson&Johnson Acuevue daily disposable lensesDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: December 2006 to July 2007
Secondary outcomes (1)
Questionaire filling by subject/parent
Measured: Dec 2006 to July 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startDec 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Investigators
- Li Lim, FRCS(Ed), Principal investigator, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473304
- Sponsor's protocol ID
- R501/50/2006
- Acronym
- CLIP
- Status last verified
- May 2010
- First submitted
- 14 May 2007
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/S0161-6420(03)00795-4.
PubMed 14644714Suchecki 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.
PubMed 11071345Solomon 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.
PubMed 8906382
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lens in Pediatrics (CLIP) in an Asian Population Study
- ClinicalTrials.gov ID
- NCT00473304
- Acronym / sponsor ID
- CLIP / R501/50/2006
- Conditions
- Myopia
- Keywords
- Safety, Efficacy, Adaptation, myopia and contact lens wear in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Dec 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Johnson&Johnson Acuevue daily disposable lenses | Device | – |
Primary outcome
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
1 secondary outcome
Questionaire filling by subject/parent
Time frame: Dec 2006 to July 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
- Background: PubMed 14644714Sankaridurg 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.
- Background: PubMed 11071345Suchecki 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.
- Background: PubMed 8906382Solomon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Lim, FRCS(Ed) principal investigator
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Johnson&Johnson Acuevue daily disposable lenses in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00473304, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.