A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

Not Applicable

Completed

Brief Summary: The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

Detailed Description: This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.

Recruitment & Eligibility

Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

Is at least 17 years of age and has full legal capacity to volunteer;
Has had a self-reported oculo-visual examination in the last two years.
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
Is willing to wear contact lens in both eyes for the duration of the study;
Has a minimum astigmatism of - 0.75, determined by refraction;
Can be fit with the two study contact lens types in the powers available;
Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
Has clear corneas and no active* ocular disease;

Exclusion Criteria

A person will be excluded from the study if he/she:

Is participating in any concurrent clinical trial;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study measure;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
Has known sensitivity to fluorescein dye or products to be used in the study;
Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery;
Has participated in the previous QUENA study.

Arm && Interventions

Group	Intervention	Description
Senofilcon C (control)	Senofilcon C (control)	Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test)	Comfilcon A (test)	Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.
Comfilcon A (test)	Senofilcon C (control)	Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.
Senofilcon C (control)	Comfilcon A (test)	Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.

Primary Outcome Measures

Name	Time	Method
Ease of Insertion(Handling)	1 month	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Ease of Insertion (Handling)	2 weeks	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

Secondary Outcome Measures