MyopiaNCT05333965
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
A study testing Lens A (lehfilcon A lens) and Lens B (comfilcon A lens) in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Lens A (lehfilcon A lens) and Lens B (comfilcon A lens)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 27 Apr 2022to 13 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is at least 17 years of age and has full legal capacity to volunteer;
- Self-reports having had a full eye examination within the previous 2 years;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is a habitual wearer of frequent replacement contact lenses;
- Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
Show all 9Show fewer
- Has refractive astigmatism no higher than -0.75DC in each eye;
- Can be successfully fit with both study lens types;
- Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.
Who cannot join
- Is participating in any concurrent clinical research study;
- Has any known active ocular disease and/or infection;
- Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
- Is an employee of the Centre for Ocular Research \& Education.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
Read the detailed description
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.
- Conditions
- Myopia
- Being tested
- Lens A (lehfilcon A lens), Lens B (comfilcon A lens)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens A (lehfilcon A lens)Device
Daily wear for 1 month.
Lens B (comfilcon A lens)Device
Daily wear for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Lens A, Then Lens B | Experimental | Participants wore Lens A for one month and then crossed over to wear Lens B for one month. Receives: Device: Lens A (lehfilcon A lens); Device: Lens B (comfilcon A lens) |
| Lens B, Then Lens A | Experimental | Participants wore Lens B for one month and then crossed over to wear Lens A for one month. Receives: Device: Lens A (lehfilcon A lens); Device: Lens B (comfilcon A lens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Handling on Lens Removal
Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start27 Apr 2022
- Primary completion13 Sep 2022
- Study completion13 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 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD FCOptom, Principal investigator, Centre for Ocular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333965
- Sponsor's protocol ID
- EX-MKTG-132
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear
- ClinicalTrials.gov ID
- NCT05333965
- Acronym / sponsor ID
- EX-MKTG-132
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.
Detailed description
This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens A, Then Lens B | Experimental | Device: Lens A (lehfilcon A lens), Device: Lens B (comfilcon A lens)Participants wore Lens A for one month and then crossed over to wear Lens B for one month. |
| Lens B, Then Lens A | Experimental | Device: Lens A (lehfilcon A lens), Device: Lens B (comfilcon A lens)Participants wore Lens B for one month and then crossed over to wear Lens A for one month. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Is at least 17 years of age and has full legal capacity to volunteer;
- Self-reports having had a full eye examination within the previous 2 years;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is a habitual wearer of frequent replacement contact lenses;
Key exclusion criteria (6 listed)
- Is participating in any concurrent clinical research study;
- Has any known active ocular disease and/or infection;
- Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
- Has known sensitivity to the diagnostic sodium fluorescein to be 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 |
|---|---|---|
| Lens A (lehfilcon A lens)Daily wear for 1 month. | Device | Lens A, Then Lens B, Lens B, Then Lens A |
| Lens B (comfilcon A lens)Daily wear for 1 month. | Device | Lens A, Then Lens B, Lens B, Then Lens A |
Primary outcome
Lens Handling on Lens Removal
Time frame: 1 month
Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- 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.
Lyndon Jones, PhD FCOptom principal investigator
Centre for Ocular Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens A (lehfilcon A lens) and Lens B (comfilcon A lens) in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.
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 9 inclusion and 6 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 23 Oct 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?
Lens Handling on Lens Removal (time frame: 1 month). 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 23 Oct 2023.