Refractive ErrorsNCT04527978
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
A study testing Verofilcon A contact lenses and Nesofilcon A contact lenses in people with Refractive Errors and Myopia, run by Alcon Research at 4 sites in United States.
Trial summary
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Myopia
- 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
- 56 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Sep 2020to 6 Nov 2020
- 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
- Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any ocular condition that contraindicates contact lens wear.
- Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alcon Investigator 6565
Maitland, Florida, 32751
Alcon Investigator 6402
Medina, Minnesota, 55340
Alcon Investigator 6313
Powell, Ohio, 43065
Alcon Investigator 8028
Wichita Falls, Texas, 76308
About this study
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
Read the detailed description
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.
- Conditions
- Refractive Errors, Myopia
- Being tested
- Verofilcon A contact lenses, Nesofilcon A contact lenses
- Keywords
- Daily disposable 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.
Verofilcon A contact lensesDevice
Also called PRECISION1™
Spherical soft contact lenses for daily disposable wear
Nesofilcon A contact lensesDevice
Also called Biotrue ONEday, Bausch + Lomb Biotrue® ONEday
Spherical soft contact lenses for daily disposable wear
| Study group | Role | What they receive |
|---|---|---|
| PRECISION1, then Biotrue ONEday | 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) for 8 -0/+3 days in a daily disposable modality. Receives: Device: Verofilcon A contact lenses; Device: Nesofilcon A contact lenses |
| Biotrue ONEday, 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) for 8 -0/+3 days in a daily disposable modality. 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.
Distance Visual Acuity (VA) With Study Lenses
Distance 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. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Measured: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, 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 posted27 Aug 2020
- Study start15 Sep 2020
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CDMA Project Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527978
- Sponsor's protocol ID
- CLE383-P003
- Status last verified
- Oct 2021
- First submitted
- 24 Aug 2020
- Last updated
- 23 Nov 2021
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
- ClinicalTrials.gov ID
- NCT04527978
- Acronym / sponsor ID
- CLE383-P003
- Conditions
- Refractive Errors, Myopia
- Keywords
- Daily disposable contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
Detailed description
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is 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 ONEday | 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) for 8 -0/+3 days in a daily disposable modality. |
| Biotrue ONEday, 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) for 8 -0/+3 days in a daily disposable modality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
- Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Any ocular condition that contraindicates contact lens wear.
- Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
- Other protocol-specified 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 ONEday, then PRECISION1, PRECISION1, then Biotrue ONEday |
| Nesofilcon A contact lensesAlso: Biotrue ONEday, Bausch + Lomb Biotrue® ONEdaySpherical soft contact lenses for daily disposable wear | Device | Biotrue ONEday, then PRECISION1, PRECISION1, then Biotrue ONEday |
Primary outcome
Distance Visual Acuity (VA) With Study Lenses
Time frame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type
Distance 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. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- 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.
CDMA Project Lead, Vision Care study director
Alcon Research, LLC
4 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 and Myopia, run by Alcon Research at 4 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 3 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 23 Nov 2021. 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 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 23 Nov 2021). 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?
Distance Visual Acuity (VA) With Study Lenses (time frame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, 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 23 Nov 2021.