Refractive ErrorsNCT05211739
Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
A study testing Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses and CLEAR CARE in people with Refractive Errors and Astigmatism, run by Alcon Research at 7 sites in United States.
Trial summary
The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type. 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?
- Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses and CLEAR CARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Feb 2022to 23 Jun 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 weekly/monthly 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;
- Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
- Able to wear contact lenses within the range of available sphere \& cylinder power and axes.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Daily disposable contact lens wearers.
- Monovision and multifocal contact lens wearers.
- Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Sabal Eye Care
Longwood, Florida, 32779
Drs. Giedd, P.A.
Maitland, Florida, 32751
SUNY College of Optometry Clinical Vision Research Center
New York, New York, 10036
Vision Health Institute
Orlando, Florida, 32803
Kannarr Eye Care LLC
Pittsburg, Kansas, 66762
West Bay Eye Associates
Warwick, Rhode Island, 02888
Fischer Laser Eye Center
Willmar, Minnesota, 56201
About this study
The purpose of this clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Read the detailed description
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
- Conditions
- Refractive Errors, Astigmatism
- Being tested
- Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses, CLEAR CARE
- Keywords
- Contact Lenses
- 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.
Lehfilcon A toric contact lensesDevice
Also called LID205255 Toric
FDA-cleared silicone hydrogel toric contact lenses used as indicated
Comfilcon A toric contact lensesDevice
Also called Biofinity Toric, CooperVision® Biofinity® Toric
Commercially available silicone hydrogel toric contact lenses used as indicated
CLEAR CAREDevice
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| LID205255 Toric, then Biofinity Toric | Other | Lehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. Receives: Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE |
| Biofinity Toric, then LID205255 Toric | Other | Comfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. Receives: Device: Lehfilcon A toric contact lenses; Device: Comfilcon A toric contact lenses; Device: CLEAR CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity (VA) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
Measured: Day 1 and Day 30, each wear period (approximately 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start15 Feb 2022
- Primary completion23 Jun 2022
- Study completion23 Jun 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 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, CRD Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211739
- Sponsor's protocol ID
- CLV201-C002
- Status last verified
- Jun 2023
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jun 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of a Daily Wear Monthly Replacement Silicone Hydrogel Toric Contact Lens
- ClinicalTrials.gov ID
- NCT05211739
- Acronym / sponsor ID
- CLV201-C002
- Conditions
- Refractive Errors, Astigmatism
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Posted 27 Jun 2023
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 clinical study is to assess the clinical performance of an investigational toric soft contact lens compared to a commercially available toric contact lens in a crossover dispense trial when worn in a daily wear modality for 30 days, each study lens type.
Detailed description
Subjects will be randomized to 1 of 2 crossover wear sequences. Subjects will be expected to attend 5 office visits, for a total individual duration of participation in the study of approximately 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID205255 Toric, then Biofinity Toric | Other | Device: Lehfilcon A toric contact lenses, Device: Comfilcon A toric contact lenses, Device: CLEAR CARELehfilcon A toric contact lenses worn first, with comfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
| Biofinity Toric, then LID205255 Toric | Other | Device: Lehfilcon A toric contact lenses, Device: Comfilcon A toric contact lenses, Device: CLEAR CAREComfilcon A toric contact lenses worn first, with lehfilcon A toric contact lenses worn second, as randomized. Each product will be worn bilaterally (in both eyes) during waking hours for at least 5 days per week, with up to 10-12 hours wear time per day over a 30-day period. CLEAR CARE will be used for nightly contact lens cleaning and disinfection. |
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 weekly/monthly 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;
- Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 20/25 Snellen in each eye.
- Able to wear contact lenses within the range of available sphere \& cylinder power and axes.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Daily disposable contact lens wearers.
- Monovision and multifocal contact lens wearers.
- Habitual Biofinity Toric/Biofinity Toric XR contact lens wearers in the past 3 months prior to consent.
- 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 |
|---|---|---|
| Lehfilcon A toric contact lensesAlso: LID205255 ToricFDA-cleared silicone hydrogel toric contact lenses used as indicated | Device | Biofinity Toric, then LID205255 Toric, LID205255 Toric, then Biofinity Toric |
| Comfilcon A toric contact lensesAlso: Biofinity Toric, CooperVision® Biofinity® ToricCommercially available silicone hydrogel toric contact lenses used as indicated | Device | Biofinity Toric, then LID205255 Toric, LID205255 Toric, then Biofinity Toric |
| CLEAR CAREHydrogen peroxide-based contact lens cleaning and disinfecting solution | Device | Biofinity Toric, then LID205255 Toric, LID205255 Toric, then Biofinity Toric |
Primary outcome
Distance Visual Acuity (VA) With Study Lenses
Time frame: Day 1 and Day 30, each wear period (approximately 30 days)
Visual acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No inferences were pre-specified for the primary effectiveness endpoint; therefore, no hypothesis testing was performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- 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.
Clinical Trial Lead, CRD Vision Care study director
Alcon Research, LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lehfilcon A toric contact lenses, Comfilcon A toric contact lenses and CLEAR CARE in people with Refractive Errors and Astigmatism, run by Alcon Research at 7 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 27 Jun 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?
Distance Visual Acuity (VA) With Study Lenses (time frame: Day 1 and Day 30, each wear period (approximately 30 days)). 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 27 Jun 2023.