Refractive ErrorsNCT05039112
Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
A study testing Verofilcon A toric contact lenses and Stenfilcon A toric contact lenses in people with Refractive Errors and Astigmatism, run by Alcon Research at 6 sites in United States.
Trial summary
The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Astigmatism
- What is being tested?
- Verofilcon A toric contact lenses and Stenfilcon A toric contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Sep 2021to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 toric 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 study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
- Current wear of spherical contact lenses.
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Alcon Investigator 6565
Maitland, Florida, 32751
Alcon Investigator 6353
Memphis, Tennessee, 38111
Alcon Investigator 6567
Pittsburg, Kansas, 66762
Alcon Investigator 6313
Powell, Ohio, 43065
Alcon Investigator 8097
Sterling Heights, Michigan, 48312
Alcon Investigator 6401
Warwick, Rhode Island, 02888
About this study
The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.
Read the detailed description
Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.
- Conditions
- Refractive Errors, Astigmatism
- Being tested
- Verofilcon A toric contact lenses, Stenfilcon A toric contact lenses
- Keywords
- Contact lenses, Daily disposable
- Medical subject headings
- Refractive Errors, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verofilcon A toric contact lensesDevice
Also called PRECISION1 for Astigmatism, P1fA
Soft contact lenses for optical correction of astigmatism, used as indicated
Stenfilcon A toric contact lensesDevice
Also called MyDay Toric
Soft contact lenses for optical correction of astigmatism, used as indicated
| Study group | Role | What they receive |
|---|---|---|
| P1fA, then MyDay Toric | Other | Verofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality. Receives: Device: Verofilcon A toric contact lenses; Device: Stenfilcon A toric contact lenses |
| MyDay Toric, then P1fA | Other | Stenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality. Receives: Device: Verofilcon A toric contact lenses; Device: Stenfilcon A toric contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Measured: Day 1, 10 minutes after lens insertion, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start28 Sep 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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
- NCT05039112
- Sponsor's protocol ID
- CLA306-E001
- Status last verified
- Dec 2021
- First submitted
- 31 Aug 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT05039112
- Acronym / sponsor ID
- CLA306-E001
- Conditions
- Refractive Errors, Astigmatism
- Keywords
- Contact lenses, Daily disposable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
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 to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.
Detailed description
Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P1fA, then MyDay Toric | Other | Device: Verofilcon A toric contact lenses, Device: Stenfilcon A toric contact lensesVerofilcon A toric contact lenses worn first, with stenfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) for 8 (-0/+3) days in a daily disposable modality. |
| MyDay Toric, then P1fA | Other | Device: Verofilcon A toric contact lenses, Device: Stenfilcon A toric contact lensesStenfilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each product 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 (3 listed)
- Successful wear of toric 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 study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
- Current wear of spherical contact lenses.
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
- 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 toric contact lensesAlso: PRECISION1 for Astigmatism, P1fASoft contact lenses for optical correction of astigmatism, used as indicated | Device | MyDay Toric, then P1fA, P1fA, then MyDay Toric |
| Stenfilcon A toric contact lensesAlso: MyDay ToricSoft contact lenses for optical correction of astigmatism, used as indicated | Device | MyDay Toric, then P1fA, P1fA, then MyDay Toric |
Primary outcome
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion
Time frame: Day 1, 10 minutes after lens insertion, each product
Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- 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
6 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 toric contact lenses and Stenfilcon A toric contact lenses in people with Refractive Errors and Astigmatism, run by Alcon Research at 6 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 3 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 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion (time frame: Day 1, 10 minutes after lens insertion, 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 7 Dec 2021.