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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01482819
Registration number
NCT01482819
Ethics application status
Date submitted
16/11/2011
Date registered
1/12/2011
Date last updated
19/06/2018
Titles & IDs
Public title
Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
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Scientific title
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Secondary ID [1]
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CR-005031
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myopia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - galyfilcon A
Treatment: Devices - galyfilcon A plus
Treatment: Devices - lotrafilcon A
Treatment: Devices - polymacon
Other interventions - spectacles
Other: Sequence 1 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Lotrafilcon A
Spectacles
Galyfilcon A Plus
Polymacon
Galyfilcon A
Other: Sequence 2 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Galyfilcon A Plus
Galyfilcon A
Lotrafilcon A
Polymacon
Spectacles
Other: Sequence 3 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Galyfilcon A
Polymacon
Galyfilcon A Plus
Spectacles
Lotrafilcon A
Other: Sequence 4 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Spectacles
Lotrafilcon A
Polymacon
Galyfilcon A Plus
Galyfilcon A
Other: Sequence 5 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Polymacon
Galyfilcon A
Spectacles
Galyfilcon A Plus
Lotrafilcon A
Other: Sequence 6 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Galyfilcon A
Galyfilcon A Plus
Polymacon
Lotrafilcon A
Spectacles
Other: Sequence 7 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Polymacon
Spectacles
Galyfilcon A
Lotrafilcon A
Galyfilcon A Plus
Other: Sequence 8 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Galyfilcon A Plus
Lotrafilcon A
Galyfilcon A
Spectacles
Polymacon
Other: Sequence 9 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Lotrafilcon A
Galyfilcon A Plus
Spectacles
Galyfilcon A
Polymacon
Other: Sequence 10 - Five separate sessions of bilateral lens wear of 8 to 12 hours; each session separated by a minimum of 24 hours. This sequence is as follows:
Spectacles
Polymacon
Lotrafilcon A
Galyfilcon A
Galyfilcon A Plus
Treatment: Devices: galyfilcon A
contact lenses worn bilaterally for 8-12 hours
Treatment: Devices: galyfilcon A plus
contact lenses worn bilaterally for 8-12 hours
Treatment: Devices: lotrafilcon A
contact lenses worn bilaterally for 8-12 hours
Treatment: Devices: polymacon
contact lenses worn bilaterally for 8-12 hours
Other interventions: spectacles
habitual spectacles owned by subject, non-specific manufacturer
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Corneal Swelling
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Assessment method [1]
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measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)
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Timepoint [1]
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after 8 hours of lens wear
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Primary outcome [2]
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Limbal Redness
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Assessment method [2]
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grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.
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Timepoint [2]
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after 8 hours of lens wear
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Primary outcome [3]
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Endothelia Blebs
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Assessment method [3]
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0 to 100% of area; measured as a percentage of corneal area with blebs.
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Timepoint [3]
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after 20 minutes of lens wear
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Eligibility
Key inclusion criteria
- Be of legal age (i.e. 18 years)
- Be of Asian descent and have -Asian eye? identifying features (see Appendix A)
- Be mentally competent, willing and able to sign a written informed consent form.
- Have contact lens distance sphere requirement in the range 1.00D to 6.00D.
- Have spectacle astigmatism <1.25D in each eye
- Currently wear soft contact lenses (for at least 3 months prior to the trial ) without
experiencing difficulties or contact lens related complications
- Have had an oculo-visual examination within the previous 12 months.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this
study a normal eye is defined as one having:
- No evidence of lid abnormality or infection
- No conjunctival abnormality or infection
- No clinically significant slit lamp findings (i.e. edema, staining, scarring,
vascularization, infiltrates or abnormal opacities)
- No other active ocular disease
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal
haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal
hyperemia, or any other abnormality of the cornea that would contraindicate contact
lens wear.
- Has had refractive surgery.
- Has had any anterior ocular surgery. Has had any other ocular surgery or injury within
8 weeks immediately prior to enrolment for this study.
- History of abnormal lachrymal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Extended lens wear in last 3 months.
- PMMA, hybrid or RGP lens wear in the previous 8 weeks
- Any systemic illness which would contraindicate lens wear or the medical treatment of
which would affect vision or successful lens wear.
- Has diabetes
- Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an
immunosuppressive disease (e.g., HIV).
- History of chronic eye disease (e.g. glaucoma or ARMD).
- Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 30 days.
- Family member or employee of the clinical site, investigator or other study staff.
- Currently wears habitual contact lenses on an EW basis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
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Accrual to date
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Final
21
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Hawthorn
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Recruitment postcode(s) [1]
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3122 - Hawthorn
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Johnson & Johnson Vision Care, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial
bleb response to wearing galyfilcon A lenses in asian eyes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01482819
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01482819
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