MyopiaNCT05805059
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses
A study testing Test Contact Lens (senofilcon A) in people with Myopia, run by CooperVision, Inc. at 4 sites in 2 countries.
Trial summary
The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Test Contact Lens (senofilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Apr 2023to 20 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self-reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Habitually wears soft contact lenses, for the past 3 months minimum;
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- No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
- No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).
Who cannot join
- Is participating in any concurrent clinical or research study;
- Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- Has undergone refractive error surgery or intraocular surgery.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
ProCare Vision Center
Granville, Ohio, 43023
Coan Eye Care
Ocoee, Florida, 34761
Sacco Eye Group, PLLC
Vestal, New York, 13850
About this study
The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.
Read the detailed description
This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week.
- Conditions
- Myopia
- Being tested
- Control Contact Lens (stenfilcon A), Test Contact Lens (senofilcon A)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Contact Lens (stenfilcon A)Device
one week wear
Test Contact Lens (senofilcon A)Device
one week of wear
| Study group | Role | What they receive |
|---|---|---|
| Control Contact Lens, Then Test Contact Lens | Experimental | Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week. Receives: Device: Control Contact Lens (stenfilcon A); Device: Test Contact Lens (senofilcon A) |
| Test Contact Lens, Then Control Contact Lens | Experimental | Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week. Receives: Device: Control Contact Lens (stenfilcon A); Device: Test Contact Lens (senofilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Handling on Removal
Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)
Measured: Collected once on day 6 at the end of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start14 Apr 2023
- Primary completion20 Jun 2023
- Study completion20 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 MyopiaStudies of the same condition, open and under way.
- 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
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Responsible party
- Sponsor
- Investigators
- Andrew Sacco, Principal investigator, Sacco Eye Group, PLLCCarolyn MacNeil, Principal investigator, Insight Eye CareKatherine Bickle, Principal investigator, ProCare Vision CenterRoxanne Achong-Coan, Principal investigator, Coan Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805059
- Sponsor's protocol ID
- EX-MKTG-145
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 26 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT05805059
- Acronym / sponsor ID
- EX-MKTG-145
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Posted 26 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.
Detailed description
This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Contact Lens, Then Test Contact Lens | Experimental | Device: Control Contact Lens (stenfilcon A), Device: Test Contact Lens (senofilcon A)Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week. |
| Test Contact Lens, Then Control Contact Lens | Experimental | Device: Control Contact Lens (stenfilcon A), Device: Test Contact Lens (senofilcon A)Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Self-reports having a full eye examination in the previous two years;
- Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
- Is willing and able to follow instructions and maintain the appointment schedule;
Key exclusion criteria (7 listed)
- Is participating in any concurrent clinical or research study;
- Has any known active ocular disease and/or infection that contraindicates contact lens wear;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- Has known sensitivity to the diagnostic sodium fluorescein used in the study;
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 |
|---|---|---|
| Control Contact Lens (stenfilcon A)one week wear | Device | Control Contact Lens, Then Test Contact Lens, Test Contact Lens, Then Control Contact Lens |
| Test Contact Lens (senofilcon A)one week of wear | Device | Control Contact Lens, Then Test Contact Lens, Test Contact Lens, Then Control Contact Lens |
Primary outcome
Lens Handling on Removal
Time frame: Collected once on day 6 at the end of wear
Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew Sacco principal investigator
Sacco Eye Group, PLLC
Carolyn MacNeil principal investigator
Insight Eye Care
Katherine Bickle principal investigator
ProCare Vision Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Contact Lens (senofilcon A) in people with Myopia, run by CooperVision, Inc. at 4 sites in 2 countries.
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 10 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 26 Sep 2024. 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, Canada. 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 26 Sep 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?
Lens Handling on Removal (time frame: Collected once on day 6 at the end of wear). 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 26 Sep 2024.