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MyopiaNCT03471832

Clinical Evaluation of Stenfilcon A Contact Lenses

A study testing stenfilcon A lens and narafilcon A lens in people with Myopia, run by CooperVision, Inc. at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myopia
What is being tested?
stenfilcon A lens and narafilcon A lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesJapan
Study dates
3 Mar 2018to 25 Apr 2018
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

  • A person is eligible for inclusion in the study if he/she:
  • Is Japanese
  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the informed consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
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  • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Currently wears soft contact lenses.
  • Has clear corneas and no active ocular disease.

Who cannot join

  • A person will be excluded from the study if he/she:
  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
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  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Shioya Eye Clinic

    Fukushima, Fukushima, 960-8034

  • Itoi Eye Clinic

    Shibuya City, Tokyo, 15-0043

  • Ueda Eye Clinic

    Shimonoseki, Yamaguchi, 751-0872

  • Kodama Eye Clinic

    Terada, Kyoto, 610-0121

Other trials in Japan

About this study

Official title: Clinical Evaluation of CooperVision MyDay Lenses

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).

Read the detailed description

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.

Conditions
Myopia
Being tested
stenfilcon A lens, narafilcon 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.

  • stenfilcon A lensDevice

    Also called MyDay, test

    contact lens

  • narafilcon A lensDevice

    Also called 1-day Acuvue TruEye, control

    contact lens

Study groups in NCT03471832
Study groupRoleWhat they receive
stenfilcon A lensExperimentalMyDay contact lens
Receives: Device: stenfilcon A lens
narafilcon A lensActive comparator1-Day Acuvue TruEye
Receives: Device: narafilcon A lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lens Movement

    Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

    Measured: 5 minutes

  2. Lens Movement

    Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

    Measured: 3hrs

  3. Horizontal Lens Centration

    Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

    Measured: 5 minutes

  4. Horizontal Lens Centration

    Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

    Measured: 3hrs

  5. Vertical Lens Centration

    Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)

    Measured: 5 minutes

  6. Vertical Lens Centration

    Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)

    Measured: 3hrs

  7. Corneal Coverage

    Does lens cover the cornea: (Yes, No)

    Measured: 5 minutes

  8. Corneal Coverage

    Does lens cover the cornea: (Yes, No)

    Measured: 3hrs

  9. Lens Lag

    Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

    Measured: 5 minutes

  10. Lens Lag

    Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

    Measured: 3hrs

  11. Overall Fitting Performance

    Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

    Measured: 5 minutes

  12. Overall Fitting Performance

    Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

    Measured: 3hrs

  13. Investigator Fit Preference

    Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)

    Measured: 5 minutes

  14. Investigator Fit Preference

    Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)

    Measured: 3hrs

Secondary outcomes (15)

  1. Comfort

    Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

    Measured: Baseline

  2. Comfort

    Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

    Measured: 5 Minutes

  3. Comfort

    Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

    Measured: 3 hours

  4. Dryness

    Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

    Measured: Baseline

  5. Dryness

    Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

    Measured: 5 minutes

  6. Dryness

    Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

    Measured: 3 hours

  7. Stinging/Burning

    Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

    Measured: Baseline

  8. Stinging/Burning

    Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

    Measured: 5 minutes

  9. Stinging/Burning

    Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

    Measured: 3 hours

  10. Edge/Lens Awareness

    Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

    Measured: Baseline

  11. Edge/Lens Awareness

    Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

    Measured: 5 minutes

  12. Edge/Lens Awareness

    Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

    Measured: 3 hours

  13. Subjective Lens Preference

    Lens preference (stenfilcon A, Either, Neither, narafilcon A)

    Measured: Baseline

  14. Subjective Lens Preference

    Lens preference (stenfilcon A, Either, Neither, narafilcon A)

    Measured: 5 minutes

  15. Subjective Lens Preference

    Lens preference (stenfilcon A, Either, Neither, narafilcon A)

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2018
  2. Study start3 Mar 2018
  3. Primary completion25 Apr 2018
  4. Study completion25 Apr 2018

Resources

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
Parallel groups
Model description
This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03471832
Sponsor's protocol ID
JP-MKTG-201709_02
Status last verified
Jan 2020
First submitted
14 Mar 2018
Last updated
29 Jan 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A lens and narafilcon A lens in people with Myopia, run by CooperVision, Inc. at 4 sites in Japan.

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 10 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 29 Jan 2020. 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 Japan. 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 29 Jan 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?

Lens Movement (time frame: 5 minutes). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03471832.

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 29 Jan 2020.

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