MyopiaNCT04005885
A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
A study testing comfilcon A, somofilcon A and stenfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial summary
This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- comfilcon A, somofilcon A and stenfilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2019to 30 Nov 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects will only be eligible for the study if:
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing soft reusable spherical contact lens wearer in both eyes.
- They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
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- They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
- They own a wearable pair of spectacles and wear them on the day of the initial visit.
- They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
- They agree not to participate in other clinical research for the duration of the study.
Who cannot join
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
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- They are pregnant or breastfeeding.
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eurolens Research - The University of Manchester
Manchester, M13 9PL
About this study
This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.
Read the detailed description
This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.
- Conditions
- Myopia
- Being tested
- comfilcon A, somofilcon A, stenfilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comfilcon ADevice
Also called Control Lens
Contact Lens
somofilcon ADevice
Also called somofilcon A daily disposable test lens, Test lens 1
daily disposable contact lens
stenfilcon ADevice
Also called stenfilcon A daily disposable test lens, Test lens 2
daily disposable contact lens
| Study group | Role | What they receive |
|---|---|---|
| somofilcon A then stenfilcon A contact lens | Experimental | Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear. Receives: Device: comfilcon A; Device: somofilcon A; Device: stenfilcon A |
| stenfilcon A then somofilcon A contact lens | Experimental | Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear. Receives: Device: comfilcon A; Device: somofilcon A; Device: stenfilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Measured: 4 weeks
Subjective Scores of Comfort on Insertion
Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Measured: 1 week
Secondary outcomes (19)
Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Measured: 4 weeks
Subjective Scores on Overall Comfort
Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Measured: 1 week
Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Measured: 4 weeks
Subjective Scores on Comfort Before Removal
Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Measured: 1 week
Number of Participants With Horizontal Lens Centration Grade
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Measured: Baseline (after 5 minutes of lens dispense)
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Measured: 4 weeks
Number of Participants With Horizontal Lens Centration Grade
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Measured: 1 week
Number of Participants With Vertical Lens Centration Grade
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Measured: Baseline (After 5 minutes of lens dispense)
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Measured: 4 weeks
Number of Participants With Vertical Lens Centration Grade
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Measured: 1 week
Number of Participants With Lens Corneal Coverage Grade
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Measured: Baseline (after 5 minutes of lens dispense)
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Measured: 4 weeks
Number of Participants With Lens Corneal Coverage Grade
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Measured: 1 week
Number of Participants With Post-Blink Movement Grade
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Measured: Baseline (after 5 minutes of lens dispense)
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Measured: 4 weeks
Number of Participants With Post-Blink Movement Grade
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Measured: 1 week
Investigator Lens Fit Acceptance
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Measured: Baseline (after 5 minutes of lens dispense)
Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Measured: 4 weeks
Investigator Lens Fit Acceptance
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Mar 2019
- Primary completion8 Nov 2019
- Study completion30 Nov 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005885
- Sponsor's protocol ID
- EX-MKTG-100
- Status last verified
- Dec 2020
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jan 2021
- 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 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT04005885
- Acronym / sponsor ID
- EX-MKTG-100
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.
Detailed description
This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| somofilcon A then stenfilcon A contact lens | Experimental | Device: comfilcon A, Device: somofilcon A, Device: stenfilcon AParticipants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear. |
| stenfilcon A then somofilcon A contact lens | Experimental | Device: comfilcon A, Device: somofilcon A, Device: stenfilcon AParticipants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects will only be eligible for the study if:
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing soft reusable spherical contact lens wearer in both eyes.
Key exclusion criteria (9 listed)
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
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 |
|---|---|---|
| comfilcon AAlso: Control LensContact Lens | Device | somofilcon A then stenfilcon A contact lens, stenfilcon A then somofilcon A contact lens |
| somofilcon AAlso: somofilcon A daily disposable test lens, Test lens 1daily disposable contact lens | Device | somofilcon A then stenfilcon A contact lens, stenfilcon A then somofilcon A contact lens |
| stenfilcon AAlso: stenfilcon A daily disposable test lens, Test lens 2daily disposable contact lens | Device | somofilcon A then stenfilcon A contact lens, stenfilcon A then somofilcon A contact lens |
Primary outcome
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
Time frame: 4 weeks
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Subjective Scores of Comfort on Insertion
Time frame: 1 week
Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
19 secondary outcomes
Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
Time frame: 4 weeks
Subjective Scores on Overall Comfort
Time frame: 1 week
Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
Time frame: 4 weeks
Subjective Scores on Comfort Before Removal
Time frame: 1 week
Number of Participants With Horizontal Lens Centration Grade
Time frame: Baseline (after 5 minutes of lens dispense)
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Time frame: 4 weeks
Number of Participants With Horizontal Lens Centration Grade
Time frame: 1 week
Number of Participants With Vertical Lens Centration Grade
Time frame: Baseline (After 5 minutes of lens dispense)
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Time frame: 4 weeks
Number of Participants With Vertical Lens Centration Grade
Time frame: 1 week
Number of Participants With Lens Corneal Coverage Grade
Time frame: Baseline (after 5 minutes of lens dispense)
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Time frame: 4 weeks
Number of Participants With Lens Corneal Coverage Grade
Time frame: 1 week
Number of Participants With Post-Blink Movement Grade
Time frame: Baseline (after 5 minutes of lens dispense)
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Time frame: 4 weeks
Number of Participants With Post-Blink Movement Grade
Time frame: 1 week
Investigator Lens Fit Acceptance
Time frame: Baseline (after 5 minutes of lens dispense)
Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Time frame: 4 weeks
Investigator Lens Fit Acceptance
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- 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.
Carole Maldonado-Codina, PhD, MCOptom, FAAO, FBCLA principal investigator
Eurolens Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comfilcon A, somofilcon A and stenfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.
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 9 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 5 Jan 2021. 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 United Kingdom. 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 11 Dec 2020). 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?
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 5 Jan 2021.