Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: Control Lens

Device: Test Lens

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06046209

CV-23-36

Details and patient eligibility

About

The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

Full description

This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.

Enrollment

30 patients

Sex

All

Ages

17 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Were 17 to 40 years of age and have full legal capacity to volunteer;
Had read and signed an information consent letter;
Were willing and able to follow instructions and maintain the appointment schedule;
Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
Had an astigmatism of ≤ 0.75DC in subjective refraction;
Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
Demonstrated an acceptable fit with the study lenses.

Exclusion criteria

Had taken part in another clinical research study within the last 14 days;
Were currently habitual wearers of toric, multifocal or monovision lenses.
Had worn any rigid contact lenses in the past 6 months
Were an extended lens wearer (i.e., sleeping with their lenses)
Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
Had amblyopia and/or distance strabismus/binocular vision problem;
Had any known active ocular disease, allergies and/or infection;
Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Had undergone refractive error surgery or intraocular surgery;
Were a member of CORE directly involved in the study.