MyopiaNCT04668989

Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

A study testing stenfilcon A - (Test lens) in people with Myopia, run by CooperVision, Inc. at 4 sites in United States.

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

The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: stenfilcon A - (Test lens)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 4 sitesUnited States
Study dates: 1 Nov 2020to 5 Feb 2021
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is at least 18 years of age 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;
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;
Habitually wears one of the study contact lenses;
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 1 country.

United States4 sites

Athens Eye Care
Athens, Ohio, 45701
Nittany Eye Associates
College, Pennsylvania, 16801
Complete Eye Care of Medina
Medina, Minnesota, 55340
Sacco Eye Group, PLLC
Vestal, New York, 13850

Other trials in United States

About this study

Read the detailed description

This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Conditions: Myopia
Being tested: stenfilcon A - (Test lens), kalifilcon A - (Control 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 - (Test lens)Device
Subjects will be randomized to wear test lenses for one week.
kalifilcon A - (Control Lens)Device
Subjects will be randomized to wear control lenses for one week.

Study groups in NCT04668989
Study group	Role	What they receive
stenfilcon A - (Test lens)	Experimental	Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week. Receives: Device: stenfilcon A - (Test lens); Device: kalifilcon A - (Control Lens)
kalifilcon A - (Control Lens)	Active comparator	Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week. Receives: Device: stenfilcon A - (Test lens); Device: kalifilcon A - (Control Lens)

What is being measured

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

Lens Wettability
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Measured: Baseline - after 2 hours of lens wear
Lens Wettability
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Measured: 1 week

Timeline

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

1 Nov 20205 Feb 2021

First posted16 Dec 2020
Study start1 Nov 2020
Primary completion5 Feb 2021
Study completion5 Feb 2021

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04668989
Sponsor's protocol ID: EX-MKTG-118
Status last verified: Sep 2021
First submitted: 4 Dec 2020
Last updated: 16 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
ClinicalTrials.gov ID: NCT04668989
Acronym / sponsor ID: EX-MKTG-118
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2020 (actual)
Primary completion: 5 Feb 2021 (actual)
Study completion: 5 Feb 2021 (actual)
First posted: 16 Dec 2020 (actual)
Results: Posted 16 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
stenfilcon A - (Test lens)	Experimental	Device: stenfilcon A - (Test lens), Device: kalifilcon A - (Control Lens)Subjects will be randomized to wear test lenses for one week then cross-over to the control lenses for one week.
kalifilcon A - (Control Lens)	Active comparator	Device: stenfilcon A - (Test lens), Device: kalifilcon A - (Control Lens)Subjects will be randomized to wear control lenses for one week then cross-over to the test lenses for one week.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Is at least 18 years of age 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 (8 listed)

Is participating in any concurrent clinical or research study;
Habitually wears one of the study contact lenses;
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;

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
stenfilcon A - (Test lens)Subjects will be randomized to wear test lenses for one week.	Device	kalifilcon A - (Control Lens), stenfilcon A - (Test lens)
kalifilcon A - (Control Lens)Subjects will be randomized to wear control lenses for one week.	Device	kalifilcon A - (Control Lens), stenfilcon A - (Test lens)

Primary outcome

Lens Wettability
Time frame: Baseline - after 2 hours of lens wear
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)
Lens Wettability
Time frame: 1 week
Lens wettability on a 0 to 4 descriptive scale, 0.5 steps (0 - Very poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 - Poor: Irregular surface appearance, drying time << blink time, 2 - Acceptable: Smooth surface appearance immediately after the blink becoming irregular after a while, drying time ≤ blink time, 3 - Good: Typical soft lens appearance with long drying time, 4 - Excellent: Appearance similar to a healthy cornea with very long drying time)

Results and safety

Results posted to the registry on 16 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stenfilcon A - (Test Lens) Then Kalifilcon A (Control Lens)	36	36
Kalifilcon A - (Control Lens) Then Stenfilcon A - (Test Lens)	30	29

Primary outcome: Lens Wettability

Time frame: Baseline - after 2 hours of lens wear. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A - (Test Lens) n = 64	Kalifilcon A - (Control Lens) n = 64
Value	3.7 (0.4)	3.7 (0.5)

Primary outcome: Lens Wettability

Time frame: 1 week. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A - (Test Lens) n = 64	Kalifilcon A - (Control Lens) n = 64
Value	3.5 (0.6)	3.5 (0.6)

Adverse events

Time frame: From dispense up to 1 week on each study lens, a total of 2 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenfilcon A - (Test Lens)	0 of 66 (0%)	1 of 66 (1.5%)	0 of 66
Kalifilcon A - (Control Lens)	0 of 66 (0%)	0 of 66 (0%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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 study director

Centre for Ocular Research & Education

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A - (Test lens) in people with Myopia, run by CooperVision, Inc. at 4 sites in United States.

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 8 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 16 Sep 2021. 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. 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 16 Sep 2021). 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 Wettability (time frame: Baseline - after 2 hours of lens wear). 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?

On the ClinicalTrials.gov record for NCT04668989.

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 16 Sep 2021.