MyopiaNCT04857723

Adaptation To and Satisfaction With Contact Lens Wear In Myopic Young Adults

A study testing daily disposable contact lens in people with Myopia, run by CooperVision, Inc. at 1 site in Canada.

Completed

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

Trial summary

The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens. Read more about this study

Who is it for?: Ages 17 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: daily disposable contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteCanada
Study dates: 22 Jul 2021to 4 Jun 2022
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 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Is between 17 and 25 years of age (inclusive) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Has a vertex corrected spherical equivalent distance refraction that ranges between - 0.75D to -6.00D in each eye;
Has astigmatism ≤ -0.75 DC in either eye, by refraction;
Be correctable to better than 0.20 logMAR in each eye by refraction;

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Has habitually worn spherical soft contact lenses to correct for distance vision (i.e. no multifocal or monovision) for the past 3 months;
Is willing to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
Demonstrates an acceptable fit with the study lenses;
Has ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.

Who cannot join

Is participating in any concurrent clinical or research study;
Has a history of amblyopia;
Has TNO Stereoacuity worse than 120" arc / or Titmus worse than 100" arc;
Has any known active ocular disease and/or infection;
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 a study outcome variable;

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Has known sensitivity to the diagnostic pharmaceutical (sodium fluorescein) to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
Is pseudophakic;
Has undergone refractive error surgery;
Has one of following experiences with MiSight lenses:
Is currently wearing MiSight lenses or
Has worn MiSight lenses for more than one week at any given time or
Has worn MiSight lenses for any more than 30 minutes in the past 30 days;
Has had orthokeratology treatment within the last 3 months.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Ocular Research & Education
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.

Read the detailed description

This was a prospective, single group, dispensing clinical trial to determine subjective and objective visual performance measures, patient satisfaction and adaptability to a commercially available daily disposable contact lens in myopic young adults over 3 months of daily lens wear.

Conditions: Myopia
Being tested: daily disposable contact lens
Medical subject headings: Myopia

What participants receive

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

daily disposable contact lensDevice
Daily disposable contact lens for 3 months

Study groups in NCT04857723
Study group	Role	What they receive
Daily disposable contact lens	Experimental	Participants wore a daily disposable contact lens for 3 months. Receives: Device: daily disposable contact lens

What is being measured

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

Subjective Quality of Vision (QoV)
The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms.
Measured: 3 months

Secondary outcomes (1)

Contact Lens Impact on Quality of Life (CLIQ)
Participant quality of life was measured after 3 months of lens wear using a CLIQ 28-item questionnaire. Each question was scored on a 1-5 integer scale, where 1=never and 5=always. As written, scores were not consistently associated with a better or worse outcome. An algorithm was later applied for consistency (i.e., for categories [1,2,3,4,5], for the first 20 questions [5,4,3,3,3] are assigned and for 21-28 [2,2,3,4,5]). After the conversion, the average of all scores was used to measure the CLIQ. The CLIQ score ranged from a minimum of 2.71 to a maximum of 5, with 5 representing the best score.
Measured: 3 months

Timeline

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

22 Jul 20214 Jun 2022

First posted23 Apr 2021
Study start22 Jul 2021
Primary completion4 Jun 2022
Study completion4 Jun 2022

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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04857723
Sponsor's protocol ID: CV-20-48
Status last verified: Jan 2022
First submitted: 20 Apr 2021
Last updated: 14 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adaptation To and Satisfaction With Contact Lens Wear In Myopic Young Adults
ClinicalTrials.gov ID: NCT04857723
Acronym / sponsor ID: CV-20-48
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Collaborators: Centre for Ocular Research & Education, Canada
Study start: 22 Jul 2021 (actual)
Primary completion: 4 Jun 2022 (actual)
Study completion: 4 Jun 2022 (actual)
First posted: 23 Apr 2021 (actual)
Results: Posted 14 Jul 2025

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 assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Daily disposable contact lens	Experimental	Device: daily disposable contact lensParticipants wore a daily disposable contact lens for 3 months.

Who may qualify

Ages: 17 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Is between 17 and 25 years of age (inclusive) and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Has a vertex corrected spherical equivalent distance refraction that ranges between - 0.75D to -6.00D in each eye;
Has astigmatism ≤ -0.75 DC in either eye, by refraction;

Key exclusion criteria (15 listed)

Is participating in any concurrent clinical or research study;
Has a history of amblyopia;
Has TNO Stereoacuity worse than 120" arc / or Titmus worse than 100" arc;
Has any known active ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect 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
daily disposable contact lensDaily disposable contact lens for 3 months	Device	Daily disposable contact lens

Primary outcome

Subjective Quality of Vision (QoV)
Time frame: 3 months
The Subjective Quality of Vision (QoV) questionnaire consisted of 30 items assessing 10 visual symptoms. Each symptom was evaluated using three sub-questions: frequency, severity, and bothersomeness. All subquestions were rated on a 4-point scale from 0 to 3, where higher values represent a higher severity, frequency, or bothersomeness. For analysis, each dimension-frequency, severity, and bothersomeness-was treated independently. Scores for each were calculated by summing the responses across all 10 symptoms, resulting in separate total scores for each dimension. Each total score ranged from 0 to 30. Thus, the Overall Frequency of Symptoms, Overall Severity, and Overall Bothersomeness scores each represent the sum of the respective ratings across all visual symptoms.

1 secondary outcome

Contact Lens Impact on Quality of Life (CLIQ)
Time frame: 3 months

Results and safety

Results posted to the registry on 14 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daily Disposable Contact Lens	29	27

Primary outcome: Subjective Quality of Vision (QoV)

Time frame: 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Daily Disposable Contact Lens n = 27
Overall Frequency	6.1 (3.6)
Overall Severity	5.3 (3.5)
Overall Bothersomeness	4.7 (4.1)

Population analysed: The 2 discontinuations occurred after lens dispensing but prior to the first follow up visit. These participants were excluded from the data analysis population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The duration of the study, approximately 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daily Disposable Contact Lens	0 of 27 (0%)	4 of 27 (14.8%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing daily disposable contact 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 10 inclusion and 15 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 14 Jul 2025. 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 14 Jul 2025). 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 Quality of Vision (QoV) (time frame: 3 months). 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 NCT04857723.

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 14 Jul 2025.