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Completed

NCT Number: NCT04857723

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

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

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Key information

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

daily disposable contact lens

Device

Daily disposable contact lens for 3 months

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Collaborators

  • Centre for Ocular Research & Education, Canada

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2021
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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