MyopiaNCT01031004
Vistakon Investigational Lens Worn as a Single Use Daily Wear
A study testing narafilcon B and etafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.
Trial summary
This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- narafilcon B and etafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2009to 1 Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- eyes must be best-corrected to a visual acuity of 20/30 or better in each eye
- must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study
- distance spherical contact lens prescription must be within the range available for the study
Who cannot join
- systemic diseases which may interfere with contact lens wear
- ocular infection or clinically significant ocular disease
- any previous intraocular surgery
- grade 2 or greater slit lamp findings
- currently pregnant or lactating
- more than 1.00D of refractive astigmatism in either eye
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Laramie, Wyoming, 82070
Study site
Salt Lake City, Utah, 84106
Study site
Virginia Beach, Virginia, 23455
About this study
This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.
- Conditions
- Myopia
- Being tested
- narafilcon B, etafilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narafilcon BDevice
contact lens
etafilcon ADevice
contact lens
| Study group | Role | What they receive |
|---|---|---|
| narafilcon B | Experimental | contact lens Receives: Device: narafilcon B |
| etafilcon A | Active comparator | contact lens Receives: Device: etafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit Lamp Findings - Corneal Edema
Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.
Measured: after 1 week of lens wear
Corneal Edema at Month 1
Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Measured: after 1 month of lens wear
Slit Lamp Findings - Corneal Neovascularization
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Measured: after 1 week of lens wear
Slit Lamp Findings - Corneal Neovascularization
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Measured: after 1 month of lens wear
Slit Lamp Findings - Corneal Staining
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Measured: after 1 week of lens wear
Slit Lamp Findings - Corneal Staining
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Measured: after 1 month of lens wear
Slit Lamp Findings - Injection
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Measured: after 1 week of lens wear
Slit Lamp Findings - Injection
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Measured: after 1 month of lens wear
Slit Lamp Findings - Tarsal Abnormalities
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Measured: after 1 week of lens wear
Slit Lamp Findings - Tarsal Abnormalities
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Measured: after 1 month of lens wear
Slit Lamp Findings - Infiltrates
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Measured: after 1 week of lens wear
Slit Lamp Findings - Infiltrates
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Measured: after 1 month of lens wear
Subject Reported Symptoms
Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.
Measured: after 1 week of lens wear
Subject Reported Symptoms
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
Measured: after 1 month of lens wear
Visual Acuity (VA)
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.
Measured: after 1 week
Visual Acuity (VA)
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.
Measured: after 1 month
Average Wear Time
Measured: after 1 week of lens wear
Average Wear Time
Measured: after 1 month of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start1 Oct 2009
- Primary completion1 Dec 2009
- Study completion1 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031004
- Sponsor's protocol ID
- CR-1655
- Status last verified
- Aug 2017
- First submitted
- 18 Nov 2009
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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
- Vistakon Investigational Lens Worn as a Single Use Daily Wear
- ClinicalTrials.gov ID
- NCT01031004
- Acronym / sponsor ID
- CR-1655
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 1 Dec 2009 (actual)
- Study completion
- 1 Dec 2009 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Posted 17 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| narafilcon B | Experimental | Device: narafilcon Bcontact lens |
| etafilcon A | Active comparator | Device: etafilcon Acontact lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- eyes must be best-corrected to a visual acuity of 20/30 or better in each eye
- must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study
- distance spherical contact lens prescription must be within the range available for the study
Key exclusion criteria (6 listed)
- systemic diseases which may interfere with contact lens wear
- ocular infection or clinically significant ocular disease
- any previous intraocular surgery
- grade 2 or greater slit lamp findings
- currently pregnant or lactating
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 |
|---|---|---|
| narafilcon Bcontact lens | Device | narafilcon B |
| etafilcon Acontact lens | Device | etafilcon A |
Primary outcome
Slit Lamp Findings - Corneal Edema
Time frame: after 1 week of lens wear
Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.
Corneal Edema at Month 1
Time frame: after 1 month of lens wear
Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Slit Lamp Findings - Corneal Neovascularization
Time frame: after 1 week of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Corneal Neovascularization
Time frame: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Corneal Staining
Time frame: after 1 week of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Corneal Staining
Time frame: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Injection
Time frame: after 1 week of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Injection
Time frame: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Tarsal Abnormalities
Time frame: after 1 week of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Tarsal Abnormalities
Time frame: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Infiltrates
Time frame: after 1 week of lens wear
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Slit Lamp Findings - Infiltrates
Time frame: after 1 month of lens wear
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Subject Reported Symptoms
Time frame: after 1 week of lens wear
Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.
Subject Reported Symptoms
Time frame: after 1 month of lens wear
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
Visual Acuity (VA)
Time frame: after 1 week
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.
Visual Acuity (VA)
Time frame: after 1 month
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.
Average Wear Time
Time frame: after 1 week of lens wear
Average Wear Time
Time frame: after 1 month of lens wear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing narafilcon B and etafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.
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 3 inclusion and 6 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 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Slit Lamp Findings - Corneal Edema (time frame: after 1 week of lens wear). The study lists 18 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.