MyopiaNCT02252133
DAILIES TOTAL1® Lens Centration in a Japanese Population
A study testing Delefilcon A contact lenses and Narafilcon A contact lenses in people with Myopia and Refractive Error, run by Alcon Research at 1 site in Japan.
Trial summary
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myopia, Refractive Error
- What is being tested?
- Delefilcon A contact lenses and Narafilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to Nov 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign Informed Consent document.
- Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
- Symptoms of contact lens discomfort as defined by protocol.
- Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
- Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
- Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
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- Acceptable contact lens fit with both study contact lenses.
- Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Currently wearing DT1 or 1DAVTE.
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
- History of herpetic keratitis, ocular surgery or irregular cornea.
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- Prior refractive surgery (e.g. LASIK, PRK, etc).
- Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
- Judged ineligible as a patient in this clinical study by the investigator.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population
The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.
- Conditions
- Myopia, Refractive Error
- Being tested
- Delefilcon A contact lenses, Narafilcon A contact lenses
- Keywords
- Contact lenses, Myopia
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delefilcon A contact lensesDevice
Also called DAILIES TOTAL1®
Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear
Narafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® TruEye®
Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear
| Study group | Role | What they receive |
|---|---|---|
| DT1, then 1DAVTE | Other | Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses |
| 1DAVTE, then DT1 | Other | Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Lens Centration After 7 ± 2 Days of Wear
Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.
Measured: Day 7, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Manager, Clinical Development, Study director, Alcon Japan, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252133
- Sponsor's protocol ID
- ALJ-V2014-1
- Status last verified
- Nov 2015
- First submitted
- 26 Sep 2014
- Last updated
- 29 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population
- ClinicalTrials.gov ID
- NCT02252133
- Acronym / sponsor ID
- ALJ-V2014-1
- Conditions
- Myopia, Refractive Error
- Keywords
- Contact lenses, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Posted 28 Dec 2015
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 compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DT1, then 1DAVTE | Other | Device: Delefilcon A contact lenses, Device: Narafilcon A contact lensesDelefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis. |
| 1DAVTE, then DT1 | Other | Device: Delefilcon A contact lenses, Device: Narafilcon A contact lensesNarafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign Informed Consent document.
- Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
- Symptoms of contact lens discomfort as defined by protocol.
- Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
- Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
Key exclusion criteria (10 listed)
- Currently wearing DT1 or 1DAVTE.
- Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
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 lensesAlso: DAILIES TOTAL1®Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear | Device | 1DAVTE, then DT1, DT1, then 1DAVTE |
| Narafilcon A contact lensesAlso: 1-DAY ACUVUE® TruEye®Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear | Device | 1DAVTE, then DT1, DT1, then 1DAVTE |
Primary outcome
Success Rate of Lens Centration After 7 ± 2 Days of Wear
Time frame: Day 7, each product
Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- 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.
Senior Manager, Clinical Development study director
Alcon Japan, 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 Delefilcon A contact lenses and Narafilcon A contact lenses in people with Myopia and Refractive Error, run by Alcon Research at 1 site in Japan.
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 9 inclusion and 10 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 29 Jan 2016. 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 Japan. 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 28 Dec 2015). 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?
Success Rate of Lens Centration After 7 ± 2 Days of Wear (time frame: Day 7, each product). 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 29 Jan 2016.