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

NCT ID: NCT04857723

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2022-06-04

Brief Summary

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daily disposable contact lens

Participants wore a daily disposable contact lens for 3 months.

Group Type: EXPERIMENTAL

daily disposable contact lens

Intervention Type: DEVICE

Daily disposable contact lens for 3 months

Interventions

daily disposable contact lens

Daily disposable contact lens for 3 months

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Ocular Research & Education, Canada

OTHER

Sponsor Role: collaborator

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CV-20-48

Identifier Type: -

Identifier Source: org_study_id