Refractive ErrorsNCT05431478
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 Errors, run by Alcon Research at 5 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 Errors
- 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
- 68 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jul 2022to 9 Sep 2022
- 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 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-specified 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
ProCare Vision Center
Granville, Ohio, 43023
Drs. Giedd, PA
Maitland, Florida, 32751
Wesley Optometric Consulting
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
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 study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).
- Conditions
- Refractive Errors
- Being tested
- Serafilcon A contact lenses, Senofilcon A contact lenses, CLEAR CARE
- Keywords
- Myopia
- Medical subject headings
- Refractive Errors, 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 daily cleaning and disinfection
Senofilcon A contact lensesDevice
Also called ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS, AOHP
Reusable silicone hydrogel contact lenses worn during the day and removed at night for daily 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 during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. Receives: Device: Serafilcon A contact lenses; Device: Senofilcon A contact lenses; Device: CLEAR CARE |
| AOHP, then LID022821 | Other | Senofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. 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.
Visual Acuity With Study Lenses at Week 1 Follow-Up
Visual acuity (VA) was assessed with study lenses in place 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. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.
Measured: Week 1, each wear period. A wear period was approximately 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start15 Jul 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, CDMA Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431478
- Sponsor's protocol ID
- CLL949-E005
- Status last verified
- Sep 2022
- First submitted
- 20 Jun 2022
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT05431478
- Acronym / sponsor ID
- CLL949-E005
- Conditions
- Refractive Errors
- Keywords
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Posted 21 Sep 2023
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 study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).
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 during Period 1, with senofilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. |
| AOHP, then LID022821 | Other | Device: Serafilcon A contact lenses, Device: Senofilcon A contact lenses, Device: CLEAR CARESenofilcon A contact lenses worn during Period 1, with serafilcon A contact lenses worn during Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection. The serafilcon A contact lenses will be replaced with a fresh pair at the Week 1 follow-up visit. |
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 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-specified 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 daily cleaning and disinfection | Device | AOHP, then LID022821, LID022821, then AOHP |
| Senofilcon A contact lensesAlso: ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS, AOHPReusable silicone hydrogel contact lenses worn during the day and removed at night for daily 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
Visual Acuity With Study Lenses at Week 1 Follow-Up
Time frame: Week 1, each wear period. A wear period was approximately 14 days.
Visual acuity (VA) was assessed with study lenses in place 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. Each eye was assessed individually. No hypothesis testing was pre-specified for this endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
Clinical Trial Lead, CDMA Vision Care study director
Alcon Research, LLC
5 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 Errors, run by Alcon Research at 5 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 21 Sep 2023). 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?
Visual Acuity With Study Lenses at Week 1 Follow-Up (time frame: Week 1, each wear period. A wear period was approximately 14 days.). 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 21 Sep 2023.