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

NCT04857723 | Completed Results

• 1 other identifier: CV-20-48
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Contact Lens Impact on Quality of Life (CLIQ)

  3 months

Study Arms (1)

Daily disposable contact lens

EXPERIMENTAL

Participants wore a daily disposable contact lens for 3 months.

Device: daily disposable contact lens

Interventions

daily disposable contact lens DEVICE

Daily disposable contact lens for 3 months

Daily disposable contact lens

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Paul Chamberlain
• Organization: CooperVision Inc.

pchamberlain@coopervision.com

+19257306754

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: July 22, 2021
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2022-01

Locations

CA (1)