MyopiaNCT03518008
Clinical Comparison of Two Daily Disposable Soft Contact Lenses
A study testing verofilcon A contact lenses and somofilcon A contact lenses in people with Myopia and Refractive Errors, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared 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
- Myopia, 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2018to 11 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and sign an Informed Consent Form;
- Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- Willing to stop wearing habitual contact lenses for the duration of study participation;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Refractive, ocular, or intraocular surgery, as specified in the protocol;
- Eye condition or injury, as specified in the protocol;
- Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
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- Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
- Currently wearing clariti® 1 day contact lenses;
- Habitually wearing monovision or multifocal lenses during the last 3 months;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.
- Conditions
- Myopia, Refractive Errors
- Being tested
- verofilcon A contact lenses, somofilcon A contact lenses
- Keywords
- soft contact lenses, vision, eyesight
- Medical subject headings
- Myopia, 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 DD T2
Investigational daily disposable soft contact lenses
somofilcon A contact lensesDevice
Also called clariti® 1 day, Clariti 1 Day
Commercially available daily disposable soft contact lenses
| Study group | Role | What they receive |
|---|---|---|
| DD T2, then Clariti 1 Day | Other | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality. Receives: Device: verofilcon A contact lenses; Device: somofilcon A contact lenses |
| Clariti 1 Day, then DD T2 | Other | Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week 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.
Overall Quality of Vision
Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
Measured: Day 8, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start23 May 2018
- Primary completion11 Jun 2018
- Study completion11 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 MyopiaStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alcon Research, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518008
- Sponsor's protocol ID
- CLE383-C006
- Status last verified
- Mar 2019
- First submitted
- 1 May 2018
- Last updated
- 3 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 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Two Daily Disposable Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT03518008
- Acronym / sponsor ID
- CLE383-C006
- Conditions
- Myopia, Refractive Errors
- Keywords
- soft contact lenses, vision, eyesight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Posted 3 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 study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DD T2, 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. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality. |
| Clariti 1 Day, then DD T2 | Other | Device: verofilcon A contact lenses, Device: somofilcon A contact lensesSomofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week 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 (5 listed)
- Understand and sign an Informed Consent Form;
- Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- Willing to stop wearing habitual contact lenses for the duration of study participation;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (10 listed)
- Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
- Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- Refractive, ocular, or intraocular surgery, as specified in the protocol;
- Eye condition or injury, as specified in the protocol;
- Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
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: DD T2Investigational daily disposable soft contact lenses | Device | Clariti 1 Day, then DD T2, DD T2, then Clariti 1 Day |
| somofilcon A contact lensesAlso: clariti® 1 day, Clariti 1 DayCommercially available daily disposable soft contact lenses | Device | Clariti 1 Day, then DD T2, DD T2, then Clariti 1 Day |
Primary outcome
Overall Quality of Vision
Time frame: Day 8, each product
Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
Alcon Research study director
Alcon Research
1 site 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 Myopia and Refractive Errors, run by Alcon Research at 1 site 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 10 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 3 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 1 site 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 3 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?
Overall Quality of Vision (time frame: Day 8, 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 3 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.