Refractive ErrorsNCT04532099
Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
A study testing Lehfilcon A contact lenses, Senofilcon A contact lenses and Comfilcon A contact lenses in people with Refractive Errors and Ametropia, run by Alcon Research at 4 sites in United States.
Trial summary
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Ametropia
- What is being tested?
- Lehfilcon A contact lenses, Senofilcon A contact lenses and Comfilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Sep 2020to 4 May 2021
- 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 an approved Informed Consent Form.
- Wear spherical 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 habitual spectacles for vision correction when study lenses are not worn, as needed.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study.
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- Routinely sleeps in contact lenses at least 1 night per week.
- Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
- Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alcon Investigator 6356
Longwood, Florida, 32779
Alcon Investigator 6565
Maitland, Florida, 32751
Alcon Investigator 6353
Memphis, Tennessee, 38111
Alcon Investigator 6401
Warwick, Rhode Island, 02888
About this study
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Read the detailed description
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.
Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.
- Conditions
- Refractive Errors, Ametropia
- Being tested
- Lehfilcon A contact lenses, Senofilcon A contact lenses, Comfilcon A contact lenses, Hydrogen peroxide-based cleaning and disinfecting 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 LID018869
Investigational soft contact lenses for daily wear worn in Part A of the study
Senofilcon A contact lensesDevice
Also called AOHP, ACUVUE OASYS® with HYDRACLEAR® PLUS
Commercially available soft contact lenses for daily wear worn in Part A of the study
Comfilcon A contact lensesDevice
Also called CooperVision® Biofinity®
Commercially available soft contact lenses for daily wear worn in Part B of the study
Hydrogen peroxide-based cleaning and disinfecting solutionDevice
Also called CLEAR CARE®
For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study
| Study group | Role | What they receive |
|---|---|---|
| LID018869, then AOHP (Part A) | Other | Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. Receives: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution |
| AOHP, then LID018869 (Part A) | Other | Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. Receives: Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution |
| Biofinity (Part B) | Active comparator | Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. Receives: Device: Comfilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity (VA) (Part A)
Distance 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. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
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 posted31 Aug 2020
- Study start9 Sep 2020
- Primary completion4 May 2021
- Study completion4 May 2021
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
- Model description
- Part A is a crossover study. Part B is a single group study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 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
- NCT04532099
- Sponsor's protocol ID
- CLY935-C020
- Status last verified
- May 2021
- First submitted
- 26 Aug 2020
- Last updated
- 3 May 2022
- 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 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT04532099
- Acronym / sponsor ID
- CLY935-C020
- Conditions
- Refractive Errors, Ametropia
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 3 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).
Detailed description
Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.
Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Part A is a crossover study. Part B is a single group study.
| Arm | Type | Receives |
|---|---|---|
| LID018869, then AOHP (Part A) | Other | Device: Lehfilcon A contact lenses, Device: Senofilcon A contact lenses, Device: Hydrogen peroxide-based cleaning and disinfecting solutionLehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| AOHP, then LID018869 (Part A) | Other | Device: Lehfilcon A contact lenses, Device: Senofilcon A contact lenses, Device: Hydrogen peroxide-based cleaning and disinfecting solutionSenofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
| Biofinity (Part B) | Active comparator | Device: Comfilcon A contact lenses, Device: Hydrogen peroxide-based cleaning and disinfecting solutionComfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution. |
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 an approved Informed Consent Form.
- Wear spherical 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 habitual spectacles for vision correction when study lenses are not worn, as needed.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study.
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- Routinely sleeps in contact lenses at least 1 night per week.
- Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.
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: LID018869Investigational soft contact lenses for daily wear worn in Part A of the study | Device | AOHP, then LID018869 (Part A), LID018869, then AOHP (Part A) |
| Senofilcon A contact lensesAlso: AOHP, ACUVUE OASYS® with HYDRACLEAR® PLUSCommercially available soft contact lenses for daily wear worn in Part A of the study | Device | AOHP, then LID018869 (Part A), LID018869, then AOHP (Part A) |
| Comfilcon A contact lensesAlso: CooperVision® Biofinity®Commercially available soft contact lenses for daily wear worn in Part B of the study | Device | Biofinity (Part B) |
| Hydrogen peroxide-based cleaning and disinfecting solutionAlso: CLEAR CARE®For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study | Device | AOHP, then LID018869 (Part A), Biofinity (Part B), LID018869, then AOHP (Part A) |
Primary outcome
Distance Visual Acuity (VA) (Part A)
Time frame: Day 30, each study lens type
Distance 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. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- 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
4 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 Comfilcon A contact lenses in people with Refractive Errors and Ametropia, run by Alcon Research at 4 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 7 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 3 May 2022). 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) (Part A) (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 3 May 2022.