Refractive ErrorsNCT04055519
Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
A study testing Lehfilcon A contact lenses, Comfilcon A contact lenses and Multi-purpose disinfection solution in people with Refractive Errors, run by Alcon Research at 3 sites in United States.
Trial summary
The purpose of this study is to obtain on-eye performance data to inform contact lens product development. 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, Comfilcon A contact lenses and Multi-purpose disinfection solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Sep 2019to 3 Dec 2019
- 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
- Sign Informed Consent document.
- Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any eye condition or disease or use of medication that contraindicates contact lens wear.
- Eye surgery, irregular cornea, eye injury as specified in the protocol.
- Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
- Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
- Habitually wears Biofinity contact lenses.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alcon Investigative Site
Bloomington, Illinois, 61704
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Memphis, Tennessee, 38111
About this study
The purpose of this study is to obtain on-eye performance data to inform contact lens product development.
Read the detailed description
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
- Conditions
- Refractive Errors
- Being tested
- Lehfilcon A contact lenses, Comfilcon A contact lenses, Multi-purpose disinfection solution
- 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 LID017569
Investigational silicone hydrogel contact lenses
Comfilcon A contact lensesDevice
Also called Biofinity®
Commercially available silicone hydrogel contact lenses
Multi-purpose disinfection solutionDevice
Also called OPTI-FREE® RepleniSH®
Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
| Study group | Role | What they receive |
|---|---|---|
| LID017569, then Biofinity | Other | Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Multi-purpose disinfection solution |
| Biofinity, then LID017569 | Other | Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection. Receives: Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Multi-purpose disinfection solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance VA (logMAR) With Study Lenses
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. No formal hypothesis testing was planned.
Measured: Day 30 after a minimum of 6 hours of wear, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start19 Sep 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CDMA Project Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055519
- Sponsor's protocol ID
- CLY935-C007
- Status last verified
- Apr 2021
- First submitted
- 12 Aug 2019
- Last updated
- 13 May 2021
- 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 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
- ClinicalTrials.gov ID
- NCT04055519
- Acronym / sponsor ID
- CLY935-C007
- Conditions
- Refractive Errors
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Posted 13 May 2021
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 obtain on-eye performance data to inform contact lens product development.
Detailed description
Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID017569, then Biofinity | Other | Device: Lehfilcon A contact lenses, Device: Comfilcon A contact lenses, Device: Multi-purpose disinfection solutionLehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection. |
| Biofinity, then LID017569 | Other | Device: Lehfilcon A contact lenses, Device: Comfilcon A contact lenses, Device: Multi-purpose disinfection solutionComfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for 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)
- Sign Informed Consent document.
- Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Any eye condition or disease or use of medication that contraindicates contact lens wear.
- Eye surgery, irregular cornea, eye injury as specified in the protocol.
- Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.
- Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.
- Habitually wears Biofinity contact lenses.
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: LID017569Investigational silicone hydrogel contact lenses | Device | Biofinity, then LID017569, LID017569, then Biofinity |
| Comfilcon A contact lensesAlso: Biofinity®Commercially available silicone hydrogel contact lenses | Device | Biofinity, then LID017569, LID017569, then Biofinity |
| Multi-purpose disinfection solutionAlso: OPTI-FREE® RepleniSH®Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses | Device | Biofinity, then LID017569, LID017569, then Biofinity |
Primary outcome
Distance VA (logMAR) With Study Lenses
Time frame: Day 30 after a minimum of 6 hours of wear, each product
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. No formal hypothesis testing was planned.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- 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.
CDMA Project Lead, Vision Care study director
Alcon Research, LLC
3 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, Comfilcon A contact lenses and Multi-purpose disinfection solution in people with Refractive Errors, run by Alcon Research at 3 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 6 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 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 13 May 2021). 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 VA (logMAR) With Study Lenses (time frame: Day 30 after a minimum of 6 hours of wear, 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 13 May 2021.