Refractive ErrorsNCT04207749
Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
A study testing LID015385 contact lenses, Comfilcon A contact lenses and CLEAR CARE in people with Refractive Errors and Myopia, run by Alcon Research at 18 sites in United States.
Trial summary
The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Errors, Myopia, Hyperopia
- What is being tested?
- LID015385 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
- 249 participants
- Where
- 18 sitesUnited States
- Study dates
- 22 Jan 2020to 17 Dec 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
- Understand and sign an IRB/IEC approved Informed Consent form.
- Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
- Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye.
- Best spectacle corrected visual acuity 20/20 or better in each eye.
- Other protocol-defined 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.
- Monovision contact lens wear.
- Any habitual wear of Biofinity lenses.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Alcon Investigator 8101
Brentwood, California, 94513
Alcon Investigator 8063
Brighton, Massachusetts, 02135
Alcon Investigator 4817
Cleveland, Ohio, 44106
Alcon Investigator 8103
Glendale, Arizona, 85308
Alcon Investigator 8102
Irvine, California, 92618
Alcon Investigator 8135
Los Angeles, California, 90012
Alcon Investigator 6565
Maitland, Florida, 32751
Alcon Investigator 6353
Memphis, Tennessee, 38111
Alcon Investigator 8100
New York, New York, 10036
Alcon Investigator 8115
Norcross, Georgia, 30071
Alcon Investigator 8108
Novato, California, 94945
Alcon Investigator 8062
Oakland, California, 94607
Alcon Investigator 6355
Orlando, Florida, 32803
Alcon Investigator 6567
Pittsburg, Kansas, 66762
Alcon Investigator 8114
Plano, Texas, 75093
Alcon Investigator 6313
Powell, Ohio, 43065
Alcon Investigator 8109
San Francisco, California, 94127
Alcon Investigator 6401
Warwick, Rhode Island, 02888
About this study
The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
Read the detailed description
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3 months.
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Being tested
- LID015385 contact lenses, Comfilcon A contact lenses, CLEAR CARE
- Keywords
- Contact Lenses
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LID015385 contact lensesDevice
Investigational soft contact lenses
Comfilcon A contact lensesDevice
Also called BIOFINITY®
Commercially available soft contact lenses
CLEAR CAREDevice
Hydrogen peroxide-based cleaning and disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| LID015385 | Experimental | LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection. Receives: Device: LID015385 contact lenses; Device: CLEAR CARE |
| Biofinity | Active comparator | Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection. 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.
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
Visual acuity (VA) was assessed for each eye individually with study lenses in place 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 lower logMAR values indicating better visual acuity.
Measured: Week 1 Follow-Up
Secondary outcomes (1)
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
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, with 20/20 Snellen visual acuity considered normal distance eyesight.
Measured: Week 1 Follow-Up, at least 4 hours after lens insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start22 Jan 2020
- Primary completion17 Dec 2020
- Study completion17 Dec 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
- 249 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
- NCT04207749
- Sponsor's protocol ID
- CLL949-C018
- Status last verified
- Jan 2022
- First submitted
- 19 Dec 2019
- Last updated
- 2 Feb 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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
- ClinicalTrials.gov ID
- NCT04207749
- Acronym / sponsor ID
- CLL949-C018
- Conditions
- Refractive Errors, Myopia, Hyperopia
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Posted 2 Feb 2022
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 safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.
Detailed description
Subjects will attend 4 office visits: Screening/Baseline/Dispense; Week 1 Follow-up; Month 1 Follow-up; and Month 3 Follow-up/Exit. The total expected duration of participation for each subject 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 |
|---|---|---|
| LID015385 | Experimental | Device: LID015385 contact lenses, Device: CLEAR CARELID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection. |
| Biofinity | Active comparator | Device: Comfilcon A contact lenses, Device: CLEAR CAREComfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly 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 (6 listed)
- Understand and sign an IRB/IEC approved Informed Consent form.
- Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
- Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye.
- Best spectacle corrected visual acuity 20/20 or better in each eye.
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.
- Monovision contact lens wear.
- Any habitual wear of Biofinity 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 |
|---|---|---|
| LID015385 contact lensesInvestigational soft contact lenses | Device | LID015385 |
| Comfilcon A contact lensesAlso: BIOFINITY®Commercially available soft contact lenses | Device | Biofinity |
| CLEAR CAREHydrogen peroxide-based cleaning and disinfecting solution | Device | Biofinity, LID015385 |
Primary outcome
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
Time frame: Week 1 Follow-Up
Visual acuity (VA) was assessed for each eye individually with study lenses in place 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 lower logMAR values indicating better visual acuity.
1 secondary outcome
Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
Time frame: Week 1 Follow-Up, at least 4 hours after lens insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LID015385 contact lenses, Comfilcon A contact lenses and CLEAR CARE in people with Refractive Errors and Myopia, run by Alcon Research at 18 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 6 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 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 2 Feb 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?
Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) (time frame: Week 1 Follow-Up). 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 2 Feb 2022.