Refractive ErrorsNCT04865354
Clinical Comparison of Two Daily Disposable Contact Lenses
A study testing Verofilcon A contact lenses and Somofilcon 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 to Clariti® 1 day 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 Somofilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 May 2021to 27 Jun 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
- Successful wearer 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.
- Possess spectacles and 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 one of the days (day prior to each week 1 visit).
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
- Any monovision and multifocal lens wearers.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alcon Investigator 6614
Franklin Park, Illinois, 60131
Alcon Investigator 8046
Granville, Ohio, 43023
Alcon Investigator 6565
Maitland, Florida, 32751
Alcon Investigator 6402
Medina, Minnesota, 55340
Alcon Investigator 8106
San Francisco, California, 94127
Alcon Investigator 6645
Shawnee Mission, Kansas, 66204
Alcon Investigator 6418
Tallahassee, Florida, 32308
Alcon Investigator 8028
Wichita Falls, Texas, 76308
About this study
The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.
Read the detailed description
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.
- Conditions
- Refractive Errors
- Being tested
- Verofilcon A contact lenses, Somofilcon A contact lenses
- Keywords
- Contact Lenses, Disposable
- 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
Somofilcon A contact lensesDevice
Also called Clariti 1-Day
Spherical soft contact lenses for daily disposable wear
| Study group | Role | What they receive |
|---|---|---|
| PRECISION1, then Clariti 1-Day | Other | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality. Receives: Device: Verofilcon A contact lenses; Device: Somofilcon A contact lenses |
| Clariti 1-Day, then PRECISION1 | Other | Somofilcon 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 days in a daily disposable modality. Receives: Device: Verofilcon A contact lenses; Device: Somofilcon 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, 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 posted29 Apr 2021
- Study start17 May 2021
- Primary completion27 Jun 2021
- Study completion27 Jun 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CDMA Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865354
- Sponsor's protocol ID
- CLE383-P005
- Status last verified
- Jun 2022
- First submitted
- 26 Apr 2021
- Last updated
- 6 Jul 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 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Two Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT04865354
- Acronym / sponsor ID
- CLE383-P005
- Conditions
- Refractive Errors
- Keywords
- Contact Lenses, Disposable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 27 Jun 2021 (actual)
- Study completion
- 27 Jun 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Posted 6 Jul 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 PRECISION1™ contact lenses to Clariti® 1 day contact lenses.
Detailed description
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation 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 Clariti 1-Day | Other | Device: Verofilcon A contact lenses, Device: Somofilcon A contact lensesVerofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality. |
| Clariti 1-Day, then PRECISION1 | Other | Device: Verofilcon A contact lenses, Device: Somofilcon A contact lensesSomofilcon 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 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)
- Successful wearer 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.
- Possess spectacles and 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 one of the days (day prior to each week 1 visit).
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.
- Any monovision and multifocal lens wearers.
- 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: PRECISION1Spherical soft contact lenses for daily disposable wear | Device | Clariti 1-Day, then PRECISION1, PRECISION1, then Clariti 1-Day |
| Somofilcon A contact lensesAlso: Clariti 1-DaySpherical soft contact lenses for daily disposable wear | Device | Clariti 1-Day, then PRECISION1, PRECISION1, then Clariti 1-Day |
Primary outcome
Least Squares Mean Distance VA (logMAR) With Study Lenses
Time frame: Day 8, 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 6 Jul 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.
CDMA 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 Somofilcon 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 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 6 Jul 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 6 Jul 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, 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 6 Jul 2022.