Status:
COMPLETED
Adaptation To and Satisfaction With Contact Lens Wear In Myopic Young Adults
Lead Sponsor:
CooperVision, Inc.
Collaborating Sponsors:
Centre for Ocular Research & Education, Canada
Conditions:
Myopia
Eligibility:
All Genders
17-25 years
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 dai...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04857723
Start Date
July 22 2021
End Date
June 4 2022
Last Update
July 14 2025
Active Locations (1)
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1
Centre for Ocular Research & Education
Waterloo, Ontario, Canada, N2L 3G1