CompletedNot Applicable

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

Canada45 participantsStarted 2018-07-23

Plain-language 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.

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;

Ease of Insertion(Handling)

Timeframe: Baseline

Ease of Insertion (Handling)

Timeframe: 2 weeks

Ease of Insertion(Handling)

Timeframe: 1 month

NCT IDNCT03684928

SponsorCooperVision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-12-14

Results submitted2020-06-09

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;