Refractive ErrorNCT00721500
A Comparison of Two Daily Disposable Contact Lenses.
A study testing etafilcon A and narafilcon A in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Refractive Error, Myopia
- What is being tested?
- etafilcon A and narafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Jul 2008
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- They are of legal age (18 years) and capacity to volunteer.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
- They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
- They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
- They have successfully worn contact lenses within six months of starting the study.
Who cannot join
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
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- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
- They have diabetes.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses
This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.
- Conditions
- Refractive Error, Myopia
- Being tested
- etafilcon A, narafilcon A
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon ADevice
Also called 1-Day Acuvue Moist
contact lens
narafilcon ADevice
Also called TruEye
contact lens
| Study group | Role | What they receive |
|---|---|---|
| narafilcon A / etafilcon A - etafilcon A - narafilcon A | Experimental | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes. Receives: Device: etafilcon A; Device: narafilcon A |
| narafilcon A / etafilcon A - narafilcon A - etafilcon A | Experimental | First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes. Receives: Device: etafilcon A; Device: narafilcon A |
| narafilcon A - etafilcon A - narafilcon A / etafilcon A | Experimental | First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. Receives: Device: etafilcon A; Device: narafilcon A |
| etafilcon A - narafilcon A - narafilcon A / etafilcon A | Experimental | First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. Receives: Device: etafilcon A; Device: narafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eyes Successfully Fit
Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.
Measured: Within 20 minutes of lens insertion
Lens Fit Decentration
Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.
Measured: Within 20 minutes of lens insertion
Lens Tightness on Cornea With Manual Digit Push Up
Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.
Measured: Within 20 minutes of lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2008
- Study completionJul 2008
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 Refractive ErrorStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721500
- Sponsor's protocol ID
- CR-0812
- Other IDs
- PROD-502
- Status last verified
- May 2015
- First submitted
- 22 Jul 2008
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT00721500
- Acronym / sponsor ID
- CR-0812
- Conditions
- Refractive Error, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Visioncare Research Ltd.
- Study start
- Jun 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Posted 2 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 seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| narafilcon A / etafilcon A - etafilcon A - narafilcon A | Experimental | Device: etafilcon A, Device: narafilcon AFirst, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes. |
| narafilcon A / etafilcon A - narafilcon A - etafilcon A | Experimental | Device: etafilcon A, Device: narafilcon AFirst, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes. |
| narafilcon A - etafilcon A - narafilcon A / etafilcon A | Experimental | Device: etafilcon A, Device: narafilcon AFirst, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. |
| etafilcon A - narafilcon A - narafilcon A / etafilcon A | Experimental | Device: etafilcon A, Device: narafilcon AFirst, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- They are of legal age (18 years) and capacity to volunteer.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
- They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
Key exclusion criteria (11 listed)
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
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 |
|---|---|---|
| etafilcon AAlso: 1-Day Acuvue Moistcontact lens | Device | etafilcon A - narafilcon A - narafilcon A / etafilcon A, narafilcon A - etafilcon A - narafilcon A / etafilcon A, narafilcon A / etafilcon A - etafilcon A - narafilcon A, narafilcon A / etafilcon A - narafilcon A - etafilcon A |
| narafilcon AAlso: TruEyecontact lens | Device | etafilcon A - narafilcon A - narafilcon A / etafilcon A, narafilcon A - etafilcon A - narafilcon A / etafilcon A, narafilcon A / etafilcon A - etafilcon A - narafilcon A, narafilcon A / etafilcon A - narafilcon A - etafilcon A |
Primary outcome
Proportion of Eyes Successfully Fit
Time frame: Within 20 minutes of lens insertion
Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.
Lens Fit Decentration
Time frame: Within 20 minutes of lens insertion
Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.
Lens Tightness on Cornea With Manual Digit Push Up
Time frame: Within 20 minutes of lens insertion
Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A and narafilcon A in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
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 7 inclusion and 11 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 21 May 2015. 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 United Kingdom. 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 2 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?
Proportion of Eyes Successfully Fit (time frame: Within 20 minutes of lens insertion). 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 21 May 2015.