MyopiaNCT01054807
Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
A study testing Galyfilcon A Habitual Lens, Galyfilcon A 8.7 BC (Investigational) and Galyfilcon A 8.3 BC (Investigational) in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Galyfilcon A Habitual Lens, Galyfilcon A 8.7 BC (Investigational) and Galyfilcon A 8.3 BC (Investigational)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2009to 1 Mar 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myopia
- Being tested
- Galyfilcon A Habitual Lens, Galyfilcon A 8.7 BC (Investigational), Galyfilcon A 8.3 BC (Investigational)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galyfilcon A Habitual LensDevice
Comparison of three soft contact lens designs.
Galyfilcon A 8.7 BC (Investigational)Device
Comparison of three soft contact lens designs.
Galyfilcon A 8.3 BC (Investigational)Device
Comparison of three soft contact lens designs
| Study group | Role | What they receive |
|---|---|---|
| GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 | Other | Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental) Receives: Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A 8.3 BC (Investigational) |
| Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL | Other | Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) Receives: Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A 8.3 BC (Investigational) |
| GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7 | Other | Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental) Receives: Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A 8.3 BC (Investigational) |
| Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3 | Other | Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental) Receives: Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A 8.3 BC (Investigational) |
| Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7 | Other | Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental) Receives: Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A 8.3 BC (Investigational) |
| Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL | Other | Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) Receives: Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A 8.3 BC (Investigational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Lens Fit Characteristics
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)
Measured: Approximately 40 minutes of wear time
Evaluation of Inter-Changeability
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)
Measured: Approximately 40 minutes of wear time
Determination of fit or Vision Differences
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)
Measured: Approximately 40 minutes of wear time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study start1 Nov 2009
- Primary completion1 Mar 2010
- Study completion1 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coles-Brennan Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Noel Brennan, McOptom PhD, Principal investigator, Coles-Brennan Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054807
- Sponsor's protocol ID
- CR-0915
- Other IDs
- CTN# 155/2009
- Status last verified
- Jun 2017
- First submitted
- 21 Jan 2010
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
- ClinicalTrials.gov ID
- NCT01054807
- Acronym / sponsor ID
- CR-0915
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Coles-Brennan Pty Ltd
- Study start
- 1 Nov 2009 (actual)
- Primary completion
- 1 Mar 2010 (actual)
- Study completion
- 1 Mar 2010 (actual)
- First posted
- 22 Jan 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 | Other | Device: Galyfilcon A Habitual Lens, Device: Galyfilcon A 8.7 BC (Investigational), Device: Galyfilcon A 8.3 BC (Investigational)Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental) |
| Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL | Other | Device: Galyfilcon A Habitual Lens, Device: Galyfilcon A 8.7 BC (Investigational), Device: Galyfilcon A 8.3 BC (Investigational)Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) |
| GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7 | Other | Device: Galyfilcon A Habitual Lens, Device: Galyfilcon A 8.7 BC (Investigational), Device: Galyfilcon A 8.3 BC (Investigational)Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental) |
| Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3 | Other | Device: Galyfilcon A Habitual Lens, Device: Galyfilcon A 8.7 BC (Investigational), Device: Galyfilcon A 8.3 BC (Investigational)Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental) |
| Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7 | Other | Device: Galyfilcon A Habitual Lens, Device: Galyfilcon A 8.7 BC (Investigational), Device: Galyfilcon A 8.3 BC (Investigational)Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental) |
| Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL | Other | Device: Galyfilcon A Habitual Lens, Device: Galyfilcon A 8.7 BC (Investigational), Device: Galyfilcon A 8.3 BC (Investigational)Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Galyfilcon A Habitual LensComparison of three soft contact lens designs. | Device | Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3, Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL, Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7, Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL, GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7, GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 |
| Galyfilcon A 8.7 BC (Investigational)Comparison of three soft contact lens designs. | Device | Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3, Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL, Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7, Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL, GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7, GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 |
| Galyfilcon A 8.3 BC (Investigational)Comparison of three soft contact lens designs | Device | Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3, Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL, Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7, Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL, GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7, GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3 |
Primary outcome
Comparison of Lens Fit Characteristics
Time frame: Approximately 40 minutes of wear time
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)
Evaluation of Inter-Changeability
Time frame: Approximately 40 minutes of wear time
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)
Determination of fit or Vision Differences
Time frame: Approximately 40 minutes of wear time
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)
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 19 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Noel Brennan, McOptom PhD principal investigator
Coles-Brennan Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galyfilcon A Habitual Lens, Galyfilcon A 8.7 BC (Investigational) and Galyfilcon A 8.3 BC (Investigational) in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.
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 6 inclusion and 9 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 19 Jun 2018. 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 Australia. 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?
Comparison of Lens Fit Characteristics (time frame: Approximately 40 minutes of wear time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2018.