Refractive ErrorsNCT04178720
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
A study testing Lehfilcon A contact lenses, Comfilcon A contact lenses and CLEAR CARE in people with Refractive Errors, run by Alcon Research at 8 sites in United States.
Trial summary
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly. 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 CLEAR CARE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Jan 2020to 10 Jun 2020
- 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 wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Habitually wearing Biofinity contact lenses.
- Monovision contact lens wearers.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alcon Investigative Site
Bloomington, Illinois, 61704
Alcon Investigative Site
Granville, Ohio, 43023
Alcon Investigative Site
Longwood, Florida, 32779
Alcon Investigative Site
Maitland, Florida, 32751
Alcon Investigative Site
Medina, Minnesota, 55340
Alcon Investigative Site
Memphis, Tennessee, 38111
Alcon Investigative Site
Memphis, Tennessee, 38119
Alcon Investigative Site
Orlando, Florida, 32803
About this study
The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
Read the detailed description
Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.
- Conditions
- Refractive Errors
- Being tested
- Lehfilcon A contact lenses, Comfilcon A contact lenses, CLEAR CARE
- Keywords
- Contact Lens, Daily Wear, Vision Correction
- 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 silicone hydrogel contact lenses
Comfilcon A contact lensesDevice
Also called CooperVision® BIOFINITY®, Biofinity
Commercially available silicone hydrogel contact lenses
CLEAR CAREDevice
Also called CLEAR CARE® Cleaning & Disinfecting Solution
Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses
| Study group | Role | What they receive |
|---|---|---|
| LID018869 | Experimental | Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. Receives: Device: Lehfilcon A contact lenses; Device: CLEAR CARE |
| Biofinity | Active comparator | Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. Receives: Device: Comfilcon A contact lenses; Device: CLEAR CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance VA (logMAR) With Study Lenses - Completed Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Distance VA (logMAR) With Study Lenses - Discontinued Eyes
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start28 Jan 2020
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 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
- NCT04178720
- Sponsor's protocol ID
- CLY935-C010
- Status last verified
- Sep 2021
- First submitted
- 25 Nov 2019
- Last updated
- 19 Oct 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 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
- ClinicalTrials.gov ID
- NCT04178720
- Acronym / sponsor ID
- CLY935-C010
- Conditions
- Refractive Errors
- Keywords
- Contact Lens, Daily Wear, Vision Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 26 Nov 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 clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.
Detailed description
Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID018869 | Experimental | Device: Lehfilcon A contact lenses, Device: CLEAR CARELehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. |
| Biofinity | Active comparator | Device: Comfilcon A contact lenses, Device: CLEAR CAREComfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Habitually wearing Biofinity contact lenses.
- Monovision contact lens wearers.
- Other protocol-specified 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: LID018869Investigational silicone hydrogel contact lenses | Device | LID018869 |
| Comfilcon A contact lensesAlso: CooperVision® BIOFINITY®, BiofinityCommercially available silicone hydrogel contact lenses | Device | Biofinity |
| CLEAR CAREAlso: CLEAR CARE® Cleaning & Disinfecting SolutionHydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses | Device | Biofinity, LID018869 |
Primary outcome
Distance VA (logMAR) With Study Lenses - Completed Eyes
Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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.
Distance VA (logMAR) With Study Lenses - Discontinued Eyes
Time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to 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 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Refractive Errors
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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
8 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 CLEAR CARE in people with Refractive Errors, run by Alcon Research at 8 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 3 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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 - Completed Eyes (time frame: Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)). The study lists 2 primary outcomes in all. 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 19 Oct 2021.