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

June 30, 2025 updated by: CooperVision, Inc.
The purpose of this study was to assess whether young adults could adapt to and achieve satisfaction with a daily disposable contact lens.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Daily disposable contact lens
Participants wore a daily disposable contact lens for 3 months.
Device: daily disposable contact lens
Daily disposable contact lens for 3 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contact Lens Impact on Quality of Life (CLIQ)
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CooperVision, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Ocular Research & Education, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV-20-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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