Refractive ErrorsNCT05010512
Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
A study testing Delefilcon A contact lenses and Kalifilcon A contact lenses in people with Refractive Errors and Ametropia, run by Alcon Research at 8 sites in United States.
Trial summary
The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Ametropia, Myopia
- What is being tested?
- Delefilcon A contact lenses and Kalifilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 8 sitesUnited States
- Study dates
- 31 Aug 2021to 12 Oct 2021
- 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
- Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
- At least 3 months of contact lens wearing experience;
- Less than or equal to 0.75 diopter (D) astigmatism in each eye;
- Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
- Monovision and/or multifocal lens wearer;
- Routinely sleeps in habitual contact lenses.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alcon Investigator 3950
Bloomington, Illinois, 61704
Alcon Investigator 6583
Eden Prairie, Minnesota, 55344
Alcon Investigator 6614
Franklin Park, Illinois, 60131
Alcon Investigator 6353
Memphis, Tennessee, 38111
Alcon Investigator 2786
Memphis, Tennessee, 38119
Alcon Investigator 6355
Orlando, Florida, 32803
Alcon Investigator 6418
Tallahassee, Florida, 32308
Alcon Investigator 3382
Wyomissing, Pennsylvania, 19610
About this study
The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
Read the detailed description
Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.
- Conditions
- Refractive Errors, Ametropia, Myopia
- Being tested
- Delefilcon A contact lenses, Kalifilcon A contact lenses
- Keywords
- Contact lenses
- 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.
Delefilcon A contact lensesDevice
Also called DAILIES TOTAL1®, DT1
Commercially available silicone hydrogel contact lenses used as indicated
Kalifilcon A contact lensesDevice
Also called Bausch + Lomb INFUSE™, Infuse
Commercially available silicone hydrogel contact lenses used as indicated
| Study group | Role | What they receive |
|---|---|---|
| DT1, then Infuse | Other | Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. Receives: Device: Delefilcon A contact lenses; Device: Kalifilcon A contact lenses |
| Infuse, then DT1 | Other | Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. Receives: Device: Delefilcon A contact lenses; Device: Kalifilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Measured: Day 8 (-0/+3), each study lens type
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start31 Aug 2021
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
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 ErrorsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010512
- Sponsor's protocol ID
- CLU484-P002
- Status last verified
- Oct 2022
- First submitted
- 11 Aug 2021
- Last updated
- 8 Nov 2022
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT05010512
- Acronym / sponsor ID
- CLU484-P002
- Conditions
- Refractive Errors, Ametropia, Myopia
- Keywords
- Contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Posted 8 Nov 2022
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 clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.
Detailed description
Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DT1, then Infuse | Other | Device: Delefilcon A contact lenses, Device: Kalifilcon A contact lensesDelefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
| Infuse, then DT1 | Other | Device: Delefilcon A contact lenses, Device: Kalifilcon A contact lensesKalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
- At least 3 months of contact lens wearing experience;
- Less than or equal to 0.75 diopter (D) astigmatism in each eye;
- Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
- Monovision and/or multifocal lens wearer;
- Routinely sleeps in habitual contact lenses.
- Other protocol-defined exclusion criteria may apply.
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®, DT1Commercially available silicone hydrogel contact lenses used as indicated | Device | DT1, then Infuse, Infuse, then DT1 |
| Kalifilcon A contact lensesAlso: Bausch + Lomb INFUSE™, InfuseCommercially available silicone hydrogel contact lenses used as indicated | Device | DT1, then Infuse, Infuse, then DT1 |
Primary outcome
Least Squares Mean Distance VA (logMAR) With Study Lenses
Time frame: Day 8 (-0/+3), each study lens type
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- 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.
Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
8 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 contact lenses and Kalifilcon A contact lenses in people with Refractive Errors and Ametropia, run by Alcon Research at 8 sites in United States.
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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 8 Nov 2022). 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?
Least Squares Mean Distance VA (logMAR) With Study Lenses (time frame: Day 8 (-0/+3), each study lens type). 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 8 Nov 2022.