AstigmatismNCT05483127
Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
A study testing Verofilcon A toric soft contact lenses and Stenfilcon A toric soft contact lenses in people with Astigmatism and Ametropia, run by Alcon Research at 11 sites in United States.
Trial summary
The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism, Ametropia, Myopia
- What is being tested?
- Verofilcon A toric soft contact lenses and Stenfilcon A toric soft contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 11 sitesUnited States
- Study dates
- 13 Sep 2022to 31 Oct 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 wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Able to wear contact lenses within a range of sphere \& cylinder power and axes.
- Willing to NOT use rewetting/lubricating drops at any time during the study.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Current or previous P1fA and MDT habitual lens wearers.
- Monovision and multifocal lens wearers.
- Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Franklin Park Eye Center
Franklin Park, Illinois, 60131
ProCare Vision Center
Granville, Ohio, 43023
Sabal Eye Care
Longwood, Florida, 32779
Kurata Eyecare Center
Los Angeles, California, 90012
Drs. Giedd, P.A.
Maitland, Florida, 32751
Wesley Optometric Consulting
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Vision Health Institute
Orlando, Florida, 32803
Kannarr Eye Care
Pittsburg, Kansas, 66762
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).
Read the detailed description
Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.
- Conditions
- Astigmatism, Ametropia, Myopia
- Being tested
- Verofilcon A toric soft contact lenses, Stenfilcon A toric soft contact lenses
- Keywords
- Contact lenses, Vision, Eye sight
- Medical subject headings
- Astigmatism, Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verofilcon A toric soft contact lensesDevice
Also called PRECISION1™ for Astigmatism, P1fA
Soft contact lenses for optical correction of ametropia and astigmatism
Stenfilcon A toric soft contact lensesDevice
Also called MyDay® toric soft contact lenses, MDT
Soft contact lenses for optical correction of ametropia and astigmatism
| Study group | Role | What they receive |
|---|---|---|
| P1fA, then MDT | Other | Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. Receives: Device: Verofilcon A toric soft contact lenses; Device: Stenfilcon A toric soft contact lenses |
| MDT, then P1fA | Other | Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. Receives: Device: Verofilcon A toric soft contact lenses; Device: Stenfilcon A toric soft contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Measured: Day 8 of each study lens type worn during the corresponding crossover period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start13 Sep 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 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 AstigmatismStudies 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483127
- Sponsor's protocol ID
- CLA306-P002
- Status last verified
- Oct 2023
- First submitted
- 29 Jul 2022
- Last updated
- 2 Nov 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT05483127
- Acronym / sponsor ID
- CLA306-P002
- Conditions
- Astigmatism, Ametropia, Myopia
- Keywords
- Contact lenses, Vision, Eye sight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Posted 2 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).
Detailed description
Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P1fA, then MDT | Other | Device: Verofilcon A toric soft contact lenses, Device: Stenfilcon A toric soft contact lensesVerofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. |
| MDT, then P1fA | Other | Device: Verofilcon A toric soft contact lenses, Device: Stenfilcon A toric soft contact lensesStenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use. |
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 wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Able to wear contact lenses within a range of sphere \& cylinder power and axes.
- Willing to NOT use rewetting/lubricating drops at any time during the study.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Current or previous P1fA and MDT habitual lens wearers.
- Monovision and multifocal lens wearers.
- Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
- 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 soft contact lensesAlso: PRECISION1™ for Astigmatism, P1fASoft contact lenses for optical correction of ametropia and astigmatism | Device | MDT, then P1fA, P1fA, then MDT |
| Stenfilcon A toric soft contact lensesAlso: MyDay® toric soft contact lenses, MDTSoft contact lenses for optical correction of ametropia and astigmatism | Device | MDT, then P1fA, P1fA, then MDT |
Primary outcome
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
Time frame: Day 8 of each study lens type worn during the corresponding crossover period
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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance 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 2 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
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.
Sr. Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
11 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 soft contact lenses and Stenfilcon A toric soft contact lenses in people with Astigmatism and Ametropia, run by Alcon Research at 11 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 2 Nov 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 Means Distance Visual Acuity With Study Lenses at Week 1 (time frame: Day 8 of each study lens type worn during the corresponding crossover period). 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 2 Nov 2023.