MyopiaNCT05805150

Performance Evaluation of Daily Disposable Contact Lenses in Habitual Lens Wearers Who Use Digital Devices Frequently

A study testing Test Lens (senofilcon A) 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.

Trial summary

The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Myopia
What is being tested?: Test Lens (senofilcon A)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 4 sitesUnited States
Study dates: 13 Mar 2023to 1 Jun 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 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Is between 18 and 35 years of age (inclusively) 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;
Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
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;

Show all 11Show fewer

Habitually wears soft contact lenses, for the past 3 months minimum;
No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
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;
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

Complete Eye Care of Medina
Medina, Minnesota, 55340
Kannarr Eye Care
Pittsburg, Kansas, 66762
Nittany Eye Associates
State College, Pennsylvania, 16801
West Bay Eye Associates
Warwick, Rhode Island, 02888

Other trials in United States

About this study

Official title: Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices

The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

Read the detailed description

This study is prospective, bilateral eye, double masked, randomized, 1 week cross-over, daily wear design involving in two different daily disposable lens types. Each lens type will be worn for approximately one week.

Conditions: Myopia
Being tested: Control Lens (stenfilcon A), Test Lens (senofilcon A)
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control Lens (stenfilcon A)Device
One week wear
Test Lens (senofilcon A)Device
One week wear

Study groups in NCT05805150
Study group	Role	What they receive
Control Lens, Then Test Lens	Experimental	Participants will wear control lenses for one week and then crossover to test lenses for one week. Receives: Device: Control Lens (stenfilcon A); Device: Test Lens (senofilcon A)
Test Lens, Then Control Lens	Experimental	Participants will wear test lenses for one week and then crossover to control lenses for one week. Receives: Device: Control Lens (stenfilcon A); Device: Test Lens (senofilcon A)

What is being measured

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

Lens Handling on Removal
Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)
Measured: Collected once on day 6 at the end of wear

Timeline

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

13 Mar 20231 Jun 2023

First posted7 Apr 2023
Study start13 Mar 2023
Primary completion1 Jun 2023
Study completion1 Jun 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: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05805150
Sponsor's protocol ID: EX-MKTG-148
Status last verified: Mar 2023
First submitted: 28 Mar 2023
Last updated: 25 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

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
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices
ClinicalTrials.gov ID: NCT05805150
Acronym / sponsor ID: EX-MKTG-148
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Collaborators: Centre for Ocular Research & Education, Canada
Study start: 13 Mar 2023 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 7 Apr 2023 (actual)
Results: Posted 25 Jun 2024

Clinical summary

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

The goal of this study is to compare the performance of two daily disposable silicone hydrogel lenses.

Detailed description

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 (stenfilcon A), Device: Test Lens (senofilcon A)Participants will wear control lenses for one week and then crossover to test lenses for one week.
Test Lens, Then Control Lens	Experimental	Device: Control Lens (stenfilcon A), Device: Test Lens (senofilcon A)Participants will wear test lenses for one week and then crossover to control lenses for one week.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Is between 18 and 35 years of age (inclusively) 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;
Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;

Key exclusion criteria (7 listed)

Is participating in any concurrent clinical or research study;
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;

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 Lens (stenfilcon A)One week wear	Device	Control Lens, Then Test Lens, Test Lens, Then Control Lens
Test Lens (senofilcon A)One week wear	Device	Control Lens, Then Test Lens, Test Lens, Then Control Lens

Primary outcome

Lens Handling on Removal
Time frame: Collected once on day 6 at the end of wear
Ease of lens removal on a 0-100 scale (0= very difficult, 100= very easy)

Results and safety

Results posted to the registry on 25 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Lens, Then Test Lens	34	34
Test Lens, Then Control Lens	35	35

Primary outcome: Lens Handling on Removal

Time frame: Collected once on day 6 at the end of wear. Median (Standard Deviation). Unit: Units on a scale

Measure	Control Lens n = 68	Test Lens n = 68
Value	90 (18)	95 (8)

Population analysed: Total Analysis Population is 68, only those who completed the study.

Adverse events

Time frame: Duration of the study, approximately 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Lens	0 of 69 (0%)	1 of 69 (1.4%)	0 of 69
Test Lens	0 of 69 (0%)	1 of 69 (1.4%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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
Hyperopia and Myopia

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.

Gina Wesley principal investigator

Complete Eye Care of Medina

Michael Cymbor principal investigator

Nittany Eye Associates

Shane Kannarr principal investigator

Kannarr Eye Care

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

Questions about this trial

What is this clinical trial studying?

A study testing Test Lens (senofilcon A) 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 11 inclusion and 7 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 25 Jun 2024. 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 25 Jun 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 on Removal (time frame: Collected once on day 6 at the end of wear). 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 NCT05805150.

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 25 Jun 2024.