Refractive AmetropiaNCT05766787
The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
A study testing Serafilcon A contact lenses, Senofilcon A contact lenses and CLEAR CARE in people with Refractive Ametropia, run by Alcon Research at 15 sites in United States.
Trial summary
The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Ametropia
- What is being tested?
- Serafilcon 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
- 190 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Mar 2023to 2 Jun 2023
- 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 soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
- Willing to stop wearing habitual contact lenses for the duration of study participation.
- Other protocol-specific inclusion criteria may apply.
Who cannot join
- Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
- Habitual wear of AOHP contact lenses.
- Habitual wear of any daily disposable contact lenses.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
The Eye Doctors Inc
Eden Prairie, Minnesota, 55344
ProCare Vision Centers, Inc.
Granville, Ohio, 43023
Omega Vision Center P.A.
Longwood, Florida, 32779
Kurata Eyecare Center
Los Angeles, California, 90013
Kindred Optics at Maitland Vision
Maitland, Florida, 32751
Complete Eye Care of Medina
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Total Eye Care PA
Memphis, Tennessee, 38119
SUNY College of Optometry Clinical Vision Research Center
New York, New York, 10036
Dr. Elsa Pao, OD
Oakland, California, 94607
Vision Health Institute
Orlando, Florida, 32803
Pacific Rims Optometry
San Francisco, California, 94127
Heart of America Eye Care
Shawnee Mission, Kansas, 66204
Tallahassee Eye Center
Tallahassee, Florida, 32308
West Bay Eye Associates
Warwick, Rhode Island, 02888
About this study
The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
Read the detailed description
In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.
- Conditions
- Refractive Ametropia
- Being tested
- Serafilcon A contact lenses, Senofilcon A contact lenses, CLEAR CARE
- Keywords
- Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serafilcon A contact lensesDevice
Also called LID022821
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
Senofilcon A contact lensesDevice
Also called ACUVUE OASYS® with HYDRACLEAR® PLUS Technology, AOHP
Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection
CLEAR CAREDevice
Also called CLEAR CARE® Cleaning and Disinfecting Solution
Hydrogen peroxide based contact lens cleaning and disinfecting solution
| Study group | Role | What they receive |
|---|---|---|
| LID022821, then AOHP | Other | Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. Receives: Device: Serafilcon A contact lenses; Device: Senofilcon A contact lenses; Device: CLEAR CARE |
| AOHP, then LID022821 | Other | Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. Receives: Device: Serafilcon 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 VA With Study Lenses at Week 1
Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Measured: Week 1 of each lens product worn during the corresponding crossover period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start29 Mar 2023
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
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 AmetropiaStudies 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead Alcon Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766787
- Sponsor's protocol ID
- CLL949-C024
- Status last verified
- May 2024
- First submitted
- 1 Mar 2023
- Last updated
- 13 Jun 2024
- 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 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT05766787
- Acronym / sponsor ID
- CLL949-C024
- Conditions
- Refractive Ametropia
- Keywords
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Posted 13 Jun 2024
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 assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
Detailed description
In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LID022821, then AOHP | Other | Device: Serafilcon A contact lenses, Device: Senofilcon A contact lenses, Device: CLEAR CARESerafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. |
| AOHP, then LID022821 | Other | Device: Serafilcon A contact lenses, Device: Senofilcon A contact lenses, Device: CLEAR CARESenofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily 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)
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
- Willing to stop wearing habitual contact lenses for the duration of study participation.
- Other protocol-specific inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
- Habitual wear of AOHP contact lenses.
- Habitual wear of any daily disposable contact lenses.
- 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 |
|---|---|---|
| Serafilcon A contact lensesAlso: LID022821Reusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection | Device | AOHP, then LID022821, LID022821, then AOHP |
| Senofilcon A contact lensesAlso: ACUVUE OASYS® with HYDRACLEAR® PLUS Technology, AOHPReusable silicone hydrogel contact lenses worn during the day and removed at night for cleaning and disinfection | Device | AOHP, then LID022821, LID022821, then AOHP |
| CLEAR CAREAlso: CLEAR CARE® Cleaning and Disinfecting SolutionHydrogen peroxide based contact lens cleaning and disinfecting solution | Device | AOHP, then LID022821, LID022821, then AOHP |
Primary outcome
Least Squares Mean Distance VA With Study Lenses at Week 1
Time frame: Week 1 of each lens product worn during the corresponding crossover period
Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- 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.
Clinical Trial Lead Alcon Vision Care study director
Alcon Research, LLC
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serafilcon A contact lenses, Senofilcon A contact lenses and CLEAR CARE in people with Refractive Ametropia, run by Alcon Research at 15 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 5 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 Jun 2024). 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 VA With Study Lenses at Week 1 (time frame: Week 1 of each lens product worn during the corresponding crossover period). 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 Jun 2024.