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

CooperVision, Inc.

Status

Completed

Conditions

Myopia

Treatments

Device: daily disposable contact lens

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04857723

CV-20-48

Details and patient eligibility

About

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

Full 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.

Enrollment

29 patients

Sex

All

Ages

17 to 25 years old

Volunteers

Accepts Healthy Volunteers

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.