MyopiaNCT01548833
Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses
A study testing Delefilcon A contact lens, Narafilcon A contact lens and Filcon II 3 contact lens in people with Myopia, run by Alcon Research.
Trial summary
The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Delefilcon A contact lens, Narafilcon A contact lens and Filcon II 3 contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2012
- 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
- Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
- Require vision correction in both eyes.
- Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
- Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
- Willing and able to wear study contact lenses 16 hours per day.
- Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
- Require monovision correction.
- Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
- Ocular surgery/trauma within the last 6 months.
- Topical or systemic antibiotic use within 7 days of enrollment.
- Topical ocular or systemic corticosteroid use within 14 days of enrollment.
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- Pregnant and nursing women.
- Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses
The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.
- Conditions
- Myopia
- Being tested
- Delefilcon A contact lens, Narafilcon A contact lens, Filcon II 3 contact lens
- Keywords
- Myopia, Contact Lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delefilcon A contact lensDevice
Also called DAILIES® TOTAL1™
Silicone hydrogel contact lens for single use, daily disposable wear.
Narafilcon A contact lensDevice
Also called 1-DAY ACUVUE® TRUEYE™
Silicone hydrogel contact lens for single use, daily disposable wear.
Filcon II 3 contact lensDevice
Also called Clariti™ 1-day
Silicone hydrogel contact lens for single use, daily disposable wear
| Study group | Role | What they receive |
|---|---|---|
| Dailies Total 1 | Experimental | Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. Receives: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Filcon II 3 contact lens |
| TruEye | Active comparator | Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. Receives: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Filcon II 3 contact lens |
| Clariti | Active comparator | Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. Receives: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Filcon II 3 contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.
Measured: Day 7, 16 hours after lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionApr 2012
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aston University
- Responsible party
- Sponsor
- Investigators
- Jami Kern, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548833
- Sponsor's protocol ID
- A00924
- Status last verified
- Jun 2013
- First submitted
- 6 Mar 2012
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT01548833
- Acronym / sponsor ID
- A00924
- Conditions
- Myopia
- Keywords
- Myopia, Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Aston University
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Posted 24 Jun 2013
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 was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dailies Total 1 | Experimental | Device: Delefilcon A contact lens, Device: Narafilcon A contact lens, Device: Filcon II 3 contact lensDelefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. |
| TruEye | Active comparator | Device: Delefilcon A contact lens, Device: Narafilcon A contact lens, Device: Filcon II 3 contact lensNarafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. |
| Clariti | Active comparator | Device: Delefilcon A contact lens, Device: Narafilcon A contact lens, Device: Filcon II 3 contact lensFilcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
- Require vision correction in both eyes.
- Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
- Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
- Willing and able to wear study contact lenses 16 hours per day.
Key exclusion criteria (9 listed)
- Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
- Require monovision correction.
- Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
- Ocular surgery/trauma within the last 6 months.
- Topical or systemic antibiotic use within 7 days of enrollment.
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 |
|---|---|---|
| Delefilcon A contact lensAlso: DAILIES® TOTAL1™Silicone hydrogel contact lens for single use, daily disposable wear. | Device | Clariti, Dailies Total 1, TruEye |
| Narafilcon A contact lensAlso: 1-DAY ACUVUE® TRUEYE™Silicone hydrogel contact lens for single use, daily disposable wear. | Device | Clariti, Dailies Total 1, TruEye |
| Filcon II 3 contact lensAlso: Clariti™ 1-daySilicone hydrogel contact lens for single use, daily disposable wear | Device | Clariti, Dailies Total 1, TruEye |
Primary outcome
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
Time frame: Day 7, 16 hours after lens insertion
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- 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.
Jami Kern, PhD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Delefilcon A contact lens, Narafilcon A contact lens and Filcon II 3 contact lens in people with Myopia, run by Alcon Research.
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 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 24 Jun 2013. 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 24 Jun 2013). 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?
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) (time frame: Day 7, 16 hours after lens insertion). 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 24 Jun 2013.