Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens

Not Applicable

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Test Lens, then Control Lens	Test Contact Lens	Participants will wear the Test Lens for 90 minutes, then crossover to the Control Lens for 90 minutes.
Control Lens, then Test Lens	Control Contact Lens	Participants will wear the Control Lens for 90 minutes, then crossover to the Test Lens for 90 minutes.
Control Lens, then Test Lens	Test Contact Lens	Participants will wear the Control Lens for 90 minutes, then crossover to the Test Lens for 90 minutes.
Test Lens, then Control Lens	Control Contact Lens	Participants will wear the Test Lens for 90 minutes, then crossover to the Control Lens for 90 minutes.

Primary Outcome Measures

Name	Time	Method
Lens Handling at Insertion	Immediately after lens application	Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.

Secondary Outcome Measures