Refractive ErrorNCT03341923
Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
A study testing Delefilcon A multifocal contact lenses and Etafilcon A multifocal contact lenses in people with Refractive Error and Presbyopia, run by Alcon Research at 4 sites in Japan.
Trial summary
The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error, Presbyopia
- What is being tested?
- Delefilcon A multifocal contact lenses and Etafilcon A multifocal contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 4 sitesJapan
- Study dates
- 20 Dec 2017to 5 Jun 2018
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign informed consent
- Habitually wear multifocal soft/ silicone hydrogel contact lenses
- Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive)
- Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance
- Willing to wear contact lenses and attend all study visits
Who cannot join
- Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses
- Any eye condition that would make contact lens wear unadvisable
- Any use of medication that would make contact lens wear unadvisable
- Prior refractive surgery
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Alcon Investigative Site
Koto-Ku, Tokyo, 136-0071
Alcon Investigative Site
Nakano-ku, Tokyo, 164-0001
Alcon Investigative Site
Shinagawa-Ku, Tokyo, 141-0021
Alcon Investigative Site
Taitō City, Tokyo, 110-0005
About this study
The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.
Read the detailed description
Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.
- Conditions
- Refractive Error, Presbyopia
- Being tested
- Delefilcon A multifocal contact lenses, Etafilcon A multifocal contact lenses
- Keywords
- contact lenses, lens centration, multifocal
- Medical subject headings
- Refractive Errors, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delefilcon A multifocal contact lensesDevice
Also called DAILIES TOTAL 1® Multifocal
Silicone hydrogel multifocal contact lenses for daily disposable wear
Etafilcon A multifocal contact lensesDevice
Also called 1-DAY ACUVUE® Moist® Multifocal
Hydrogel multifocal contact lenses for daily disposable wear
| Study group | Role | What they receive |
|---|---|---|
| DT1MF, then AMMF | Other | Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days. Receives: Device: Delefilcon A multifocal contact lenses; Device: Etafilcon A multifocal contact lenses |
| AMMF, then DT1MF | Other | Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days. Receives: Device: Delefilcon A multifocal contact lenses; Device: Etafilcon A multifocal contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.
Measured: Day 14, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start20 Dec 2017
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
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.
- 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
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341923
- Sponsor's protocol ID
- CLJ369-P001
- Status last verified
- Mar 2019
- First submitted
- 9 Nov 2017
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
- ClinicalTrials.gov ID
- NCT03341923
- Acronym / sponsor ID
- CLJ369-P001
- Conditions
- Refractive Error, Presbyopia
- Keywords
- contact lenses, lens centration, multifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 16 Apr 2019
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 clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.
Detailed description
Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DT1MF, then AMMF | Other | Device: Delefilcon A multifocal contact lenses, Device: Etafilcon A multifocal contact lensesDelefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days. |
| AMMF, then DT1MF | Other | Device: Delefilcon A multifocal contact lenses, Device: Etafilcon A multifocal contact lensesEtafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign informed consent
- Habitually wear multifocal soft/ silicone hydrogel contact lenses
- Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive)
- Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance
- Willing to wear contact lenses and attend all study visits
Key exclusion criteria (4 listed)
- Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses
- Any eye condition that would make contact lens wear unadvisable
- Any use of medication that would make contact lens wear unadvisable
- Prior 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 |
|---|---|---|
| Delefilcon A multifocal contact lensesAlso: DAILIES TOTAL 1® MultifocalSilicone hydrogel multifocal contact lenses for daily disposable wear | Device | AMMF, then DT1MF, DT1MF, then AMMF |
| Etafilcon A multifocal contact lensesAlso: 1-DAY ACUVUE® Moist® MultifocalHydrogel multifocal contact lenses for daily disposable wear | Device | AMMF, then DT1MF, DT1MF, then AMMF |
Primary outcome
Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
Time frame: Day 14, each product
Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delefilcon A multifocal contact lenses and Etafilcon A multifocal contact lenses in people with Refractive Error and Presbyopia, run by Alcon Research at 4 sites 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 5 inclusion and 4 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 16 Apr 2019). 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?
Percentage of Subjects With Investigator-graded Lens Centration of "Optimal" (time frame: Day 14, 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 16 Apr 2019.