MyopiaNCT01097863
Clinical Validation of the New Print on Focus DAILIES Toric
A study testing nelfilcon A contact lens, modified inversion indicator, nelfilcon A contact lens, no inversion indicator and nelfilcon A contact lens, inversion indicator in people with Myopia, run by CIBA VISION.
Trial summary
The purpose of this study is to validate the improvements to the inversion indicator. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myopia
- What is being tested?
- nelfilcon A contact lens, modified inversion indicator, nelfilcon A contact lens, no inversion indicator and nelfilcon A contact lens, inversion indicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to May 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
- Willing and able to wear study lenses in both eyes in the available parameters.
- Light-eyed subjects.
- Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
- Optimal or acceptable fit in each eye at time of dispensing.
- Willing to wear the study lenses at least 8 hours a day, 5 days a week.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye injury or surgery within twelve weeks prior to enrollment for this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- RGP contact lens wearer.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to validate the improvements to the inversion indicator.
Read the detailed description
This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.
- Conditions
- Myopia
- Being tested
- nelfilcon A contact lens, modified inversion indicator, nelfilcon A contact lens, no inversion indicator, nelfilcon A contact lens, inversion indicator
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nelfilcon A contact lens, modified inversion indicatorDevice
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
nelfilcon A contact lens, no inversion indicatorDevice
Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
nelfilcon A contact lens, inversion indicatorDevice
Also called Focus DAILIES Toric
Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator
| Study group | Role | What they receive |
|---|---|---|
| nelfilcon A, modified inversion indicator | Experimental | Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week Receives: Device: nelfilcon A contact lens, modified inversion indicator |
| nelfilcon A, no inversion indicator | Experimental | Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week Receives: Device: nelfilcon A contact lens, no inversion indicator |
| nelfilcon A, inversion indicator | Active comparator | Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. Receives: Device: nelfilcon A contact lens, inversion indicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
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
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIBA VISION
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097863
- Sponsor's protocol ID
- P-346-C-010
- Status last verified
- Jan 2012
- First submitted
- 31 Mar 2010
- Last updated
- 10 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the New Print on Focus DAILIES Toric
- ClinicalTrials.gov ID
- NCT01097863
- Acronym / sponsor ID
- P-346-C-010
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- CIBA VISIONIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 27 Jun 2011
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 study is to validate the improvements to the inversion indicator.
Detailed description
This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nelfilcon A, modified inversion indicator | Experimental | Device: nelfilcon A contact lens, modified inversion indicatorNelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
| nelfilcon A, no inversion indicator | Experimental | Device: nelfilcon A contact lens, no inversion indicatorNelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week |
| nelfilcon A, inversion indicator | Active comparator | Device: nelfilcon A contact lens, inversion indicatorNelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
- Willing and able to wear study lenses in both eyes in the available parameters.
- Light-eyed subjects.
- Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
- Optimal or acceptable fit in each eye at time of dispensing.
Key exclusion criteria (7 listed)
- Eye injury or surgery within twelve weeks prior to enrollment for this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
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 |
|---|---|---|
| nelfilcon A contact lens, modified inversion indicatorInvestigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator | Device | nelfilcon A, modified inversion indicator |
| nelfilcon A contact lens, no inversion indicatorInvestigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator | Device | nelfilcon A, no inversion indicator |
| nelfilcon A contact lens, inversion indicatorAlso: Focus DAILIES ToricCommercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator | Device | nelfilcon A, inversion indicator |
Primary outcome
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.
Time frame: 1 week
As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, "Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion?" The positive "yes" responses are reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing nelfilcon A contact lens, modified inversion indicator, nelfilcon A contact lens, no inversion indicator and nelfilcon A contact lens, inversion indicator in people with Myopia, run by CIBA VISION.
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 7 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 27 Jun 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?
Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. (time frame: 1 week). 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 10 Jul 2012.