Refractive ErrorsNCT05138783
Clinical Performance of Two Daily Disposable Soft Contact Lenses
A study testing Verofilcon A contact lenses and Nesofilcon A contact lenses in people with Refractive Errors, run by Alcon Research at 8 sites in United States.
Trial summary
The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Verofilcon A contact lenses and Nesofilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Jan 2022to 7 Mar 2022
- 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
- Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
- Monovision and multifocal lens wear.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Franklin Park Eye Center PC
Franklin Park, Illinois, 60131
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Kindred Optics at Maitland Vision
Maitland, Florida, 32751
Complete Eye Care Of Medina
Medina, Minnesota, 55340
Heart of America Eye Care
Shawnee Mission, Kansas, 66204
Tallahassee Eye Center
Tallahassee, Florida, 32308
Stine Eye Center
Weston, Wisconsin, 54476
Clarke EyeCare Center
Wichita Falls, Texas, 76308
About this study
The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.
Read the detailed description
Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.
- Conditions
- Refractive Errors
- Being tested
- Verofilcon A contact lenses, Nesofilcon A contact lenses
- Keywords
- Contact Lenses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verofilcon A contact lensesDevice
Also called PRECISION1™
Spherical soft contact lenses for daily disposable wear
Nesofilcon A contact lensesDevice
Also called Biotrue® ONEday
Spherical soft contact lenses for daily disposable wear
| Study group | Role | What they receive |
|---|---|---|
| PRECISION1, then Biotrue | Other | Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. Receives: Device: Verofilcon A contact lenses; Device: Nesofilcon A contact lenses |
| Biotrue, then PRECISION1 | Other | Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. Receives: Device: Verofilcon A contact lenses; Device: Nesofilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Measured: Day 8 (-0/+3 days), 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 posted1 Dec 2021
- Study start12 Jan 2022
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
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
- 129 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
- NCT05138783
- Sponsor's protocol ID
- CLE383-P006
- Status last verified
- Mar 2023
- First submitted
- 15 Nov 2021
- Last updated
- 18 Apr 2023
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two Daily Disposable Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT05138783
- Acronym / sponsor ID
- CLE383-P006
- Conditions
- Refractive Errors
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 18 Apr 2023
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 PRECISION1 contact lenses with Biotrue contact lenses.
Detailed description
Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be up to 22 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRECISION1, then Biotrue | Other | Device: Verofilcon A contact lenses, Device: Nesofilcon A contact lensesVerofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. |
| Biotrue, then PRECISION1 | Other | Device: Verofilcon A contact lenses, Device: Nesofilcon A contact lensesNesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses will be worn each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.
- Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear.
- Monovision and multifocal lens wear.
- 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 |
|---|---|---|
| Verofilcon A contact lensesAlso: PRECISION1™Spherical soft contact lenses for daily disposable wear | Device | Biotrue, then PRECISION1, PRECISION1, then Biotrue |
| Nesofilcon A contact lensesAlso: Biotrue® ONEdaySpherical soft contact lenses for daily disposable wear | Device | Biotrue, then PRECISION1, PRECISION1, then Biotrue |
Primary outcome
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
Time frame: Day 8 (-0/+3 days), each study lens type
Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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 Verofilcon A contact lenses and Nesofilcon A contact lenses in people with Refractive Errors, 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 4 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 18 Apr 2023. 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 18 Apr 2023). 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 Visual Acuity (VA) With Study Lenses (time frame: Day 8 (-0/+3 days), 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 18 Apr 2023.