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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01054807
Registration number
NCT01054807
Ethics application status
Date submitted
21/01/2010
Date registered
22/01/2010
Titles & IDs
Public title
Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
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Scientific title
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Secondary ID [1]
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CTN# 155/2009
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Secondary ID [2]
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CR-0915
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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 Habitual Lens
Treatment: Devices - Galyfilcon A 8.7 BC (Investigational)
Treatment: Devices - Galyfilcon A 8.3 BC (Investigational)
Other: GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 - Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Other: Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL - Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Other: GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7 - Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Other: Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3 - Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Other: Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7 - Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Other: Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL - Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Treatment: Devices: Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
Treatment: Devices: Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
Treatment: Devices: Galyfilcon A 8.3 BC (Investigational)
Comparison of three soft contact lens designs
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Intervention code [1]
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Treatment: Devices
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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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Comparison of Lens Fit Characteristics
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Assessment method [1]
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At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control):
* Visual Acuity (logMar)
* Over-refraction with Visual Acuity
* Fit acceptability (acceptable/non-acceptable)
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Timepoint [1]
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Approximately 40 minutes of wear time
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Primary outcome [2]
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Evaluation of Inter-Changeability
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Assessment method [2]
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In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed:
* Ease of handling of the lenses- by Investigator
* Comfort on insertion
After 30-40 minutes of settling time the following variables will be collected:
* Subjective comfort after settling
* Visual Acuity (logMar)
* Corneal coverage (Y/N)
* Post-blink movement (mm)
* Version Lag (mm)
* Tightness on push-up (0-100 scale)
* Overall fit acceptance (0-5 scale)
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Timepoint [2]
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Approximately 40 minutes of wear time
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Primary outcome [3]
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Determination of fit or Vision Differences
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Assessment method [3]
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In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed:
* Ease of handling of the lenses- by Investigator
* Comfort on insertion
After 30-40 minutes of settling time the following variables will be collected:
* Subjective comfort after settling
* Visual Acuity (logMar)
* Corneal coverage (Y/N)
* Post-blink movement (mm)
* Version Lag (mm)
* Tightness on push-up (0-100 scale)
* Overall fit acceptance (0-5 scale)
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Timepoint [3]
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Approximately 40 minutes of wear time
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Eligibility
Key inclusion criteria
* Be of legal age (i.e., at least 18 years old)
* Sign a written informed consent
* Have contact lens distance sphere requirement in the range -1.00D to -6.00D
* Have spectacle astigmatism <1.25D in each eye
* Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
* Have normal eyes with no evidence of abnormality or 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
* Required concurrent ocular medication
* Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Eye injury or surgery within eight 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 enrolment.
* Participation in any concurrent clinical trial
* Known allergy to silver, silver ions, or silver containing compounds.
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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
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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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
1/11/2009
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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
1/03/2010
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Coles-Brennan Pty Ltd - 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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Other collaborator category [1]
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Other
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Name [1]
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Coles-Brennan Pty Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.
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Trial website
https://clinicaltrials.gov/study/NCT01054807
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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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Noel Brennan, McOptom PhD
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Address
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Coles-Brennan Pty Ltd
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01054807