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

CooperVision

Status: Completed

Conditions: Astigmatism Bilateral

Treatments: Device: Senofilcon C (control); Device: Comfilcon A (test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03684928

EX-MKTG-94

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has had a self-reported oculo-visual examination in the last two years.
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. 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.
6. Is willing to wear contact lens in both eyes for the duration of the study;
7. Has a minimum astigmatism of - 0.75, determined by refraction;
8. Can be fit with the two study contact lens types in the powers available;
9. Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
10. Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
11. Has clear corneas and no active* ocular disease;

Exclusion criteria

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

1. Is participating in any concurrent clinical trial;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study measure;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
5. Has known sensitivity to fluorescein dye or products to be used in the study;
6. 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;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
8. Is aphakic;
9. Has undergone refractive error surgery;
10. Has participated in the previous QUENA study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Comfilcon A (test)

Active Comparator group

Description:

Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.

Treatment:

Device: Comfilcon A (test)

Device: Senofilcon C (control)

Senofilcon C (control)

Active Comparator group

Description:

Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.

Treatment:

Device: Comfilcon A (test)

Device: Senofilcon C (control)