MyopiaNCT06046209
Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens
A study testing Test Lens in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers. Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- Test Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2023to 22 Nov 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 17 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Were 17 to 40 years of age and have full legal capacity to volunteer;
- Had read and signed an information consent letter;
- Were willing and able to follow instructions and maintain the appointment schedule;
- Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
- Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
- Had an astigmatism of ≤ 0.75DC in subjective refraction;
- Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
- Demonstrated an acceptable fit with the study lenses.
Who cannot join
- Had taken part in another clinical research study within the last 14 days;
- Were currently habitual wearers of toric, multifocal or monovision lenses.
- Had worn any rigid contact lenses in the past 6 months
- Were an extended lens wearer (i.e., sleeping with their lenses)
- Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
- Had amblyopia and/or distance strabismus/binocular vision problem;
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- Had any known active ocular disease, allergies and/or infection;
- Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Had undergone refractive error surgery or intraocular surgery;
- Were a member of CORE directly involved in the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, N2L 3G1
About this study
Official title: Comparing Clariti Elite Versus Proclear 1 Day
The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
Read the detailed description
This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.
- Conditions
- Myopia
- Being tested
- Control Lens, Test Lens
- Keywords
- Refractive Errors, Eye Diseases
- Medical subject headings
- Myopia, Refractive Errors, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control LensDevice
Daily disposable contact lens for 90 minutes
Test LensDevice
Monthly replacement contact lens for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control Lens, then Test Lens | Experimental | Participants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes. Receives: Device: Control Lens; Device: Test Lens |
| Test Lens, then Control Lens | Experimental | Participants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes. Receives: Device: Control Lens; Device: Test Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Handling at Insertion
Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.
Measured: Immediately after lens application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start28 Sep 2023
- Primary completion22 Nov 2023
- Study completion22 Nov 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
- 30 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
- Lyndon Jones, PhD FCOptom, Principal investigator, Centre for Ocular Research and Education (CORE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046209
- Sponsor's protocol ID
- CV-23-36
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2023
- Last updated
- 12 Dec 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Clariti Elite Versus Proclear 1 Day
- ClinicalTrials.gov ID
- NCT06046209
- Acronym / sponsor ID
- CV-23-36
- Conditions
- Myopia
- Keywords
- Refractive Errors, Eye Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 12 Dec 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 was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
Detailed description
This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Lens, then Test Lens | Experimental | Device: Control Lens, Device: Test LensParticipants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes. |
| Test Lens, then Control Lens | Experimental | Device: Control Lens, Device: Test LensParticipants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Were 17 to 40 years of age and have full legal capacity to volunteer;
- Had read and signed an information consent letter;
- Were willing and able to follow instructions and maintain the appointment schedule;
- Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
- Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
Key exclusion criteria (12 listed)
- Had taken part in another clinical research study within the last 14 days;
- Were currently habitual wearers of toric, multifocal or monovision lenses.
- Had worn any rigid contact lenses in the past 6 months
- Were an extended lens wearer (i.e., sleeping with their lenses)
- Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
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 LensDaily disposable contact lens for 90 minutes | Device | Control Lens, then Test Lens, Test Lens, then Control Lens |
| Test LensMonthly replacement contact lens for 90 minutes | Device | Control Lens, then Test Lens, Test Lens, then Control Lens |
Primary outcome
Lens Handling at Insertion
Time frame: Immediately after lens application
Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 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.
Lyndon Jones, PhD FCOptom principal investigator
Centre for Ocular Research and Education (CORE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test 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 8 inclusion and 12 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 12 Dec 2024. 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 12 Dec 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 at Insertion (time frame: Immediately after lens application). 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 12 Dec 2024.