Refractive ErrorsNCT05050578
Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
A study testing Lehfilcon A contact lenses, Senofilcon A contact lenses and CLEAR CARE in people with Refractive Errors, run by Alcon Research at 10 sites in United States.
Trial summary
The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear. 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?
- Lehfilcon A contact lenses, Senofilcon A contact lenses and CLEAR CARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Nov 2021to 22 Feb 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
- Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Manifest cylinder less than or equal to 0.75 diopter in each eye.
- Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Monovision or multifocal lens wearer.
- Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
- Routinely sleeps in habitual contact lenses.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
North Spartanburg Eye Center
Boiling Springs, South Carolina, 29316
Sabal Eye Care
Longwood, Florida, 32779
Optometry Group, PLLC
Memphis, Tennessee, 38111
Dr. Elsa Pao, OD
Oakland, California, 94607
Vision Health Institute
Orlando, Florida, 32803
Dr Christina R Chang & Associates, OD, PA
Plano, Texas, 75093
Dawn M. Rakich, OD
San Antonio, Texas, 78213
Pacific Rims Optometry
San Francisco, California, 94127
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.
Read the detailed description
Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.
- Conditions
- Refractive Errors
- Being tested
- Lehfilcon A contact lenses, Senofilcon A contact lenses, CLEAR CARE
- Keywords
- Contact lenses
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lehfilcon A contact lensesDevice
Also called LID018869
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
Senofilcon A contact lensesDevice
Also called AOHP
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
CLEAR CAREDevice
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| LID018869, then AOHP | Other | Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: CLEAR CARE |
| AOHP, then LID018869 | Other | Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: CLEAR CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters 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.
Measured: Day 30, 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 posted20 Sep 2021
- Study start2 Nov 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, CDMA Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050578
- Sponsor's protocol ID
- CLY935-C022
- Status last verified
- Mar 2023
- First submitted
- 10 Sep 2021
- Last updated
- 16 Mar 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 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT05050578
- Acronym / sponsor ID
- CLY935-C022
- Conditions
- Refractive Errors
- Keywords
- Contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Posted 16 Mar 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 study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.
Detailed description
Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID018869, then AOHP | Other | Device: Lehfilcon A contact lenses, Device: Senofilcon A contact lenses, Device: CLEAR CARELehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily contact lens cleaning and disinfection. |
| AOHP, then LID018869 | Other | Device: Lehfilcon A contact lenses, Device: Senofilcon A contact lenses, Device: CLEAR CARESenofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product will be worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE will be used for daily 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)
- Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
- Manifest cylinder less than or equal to 0.75 diopter in each eye.
- Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Monovision or multifocal lens wearer.
- Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
- Routinely sleeps in habitual contact lenses.
- 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 contact lensesAlso: LID018869Commercially available, silicone hydrogel, spherical contact lenses used as indicated | Device | AOHP, then LID018869, LID018869, then AOHP |
| Senofilcon A contact lensesAlso: AOHPCommercially available, silicone hydrogel, spherical contact lenses used as indicated | Device | AOHP, then LID018869, LID018869, then AOHP |
| CLEAR CAREHydrogen peroxide-based contact lens cleaning and disinfecting solution | Device | AOHP, then LID018869, LID018869, then AOHP |
Primary outcome
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
Time frame: Day 30, each study lens type
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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.
Sr. Clinical Trial Lead, CDMA Vision Care study director
Alcon Research, LLC
10 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 contact lenses, Senofilcon A contact lenses and CLEAR CARE in people with Refractive Errors, run by Alcon Research at 10 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 16 Mar 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 Mean Distance Visual Acuity With Study Lenses at Day 30 (time frame: Day 30, 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 16 Mar 2023.