Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: samfilcon A toric lens; Device: comfilcon A toric lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03519932

EX-MKTG-91

Details and patient eligibility

About

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Enrollment: 49 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

• 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 PIANO (i.e. EX-MKTG-83) Study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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49 participants in 2 patient groups

comfilcon A toric lens

Experimental group

Description:

Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.

Treatment:

Device: comfilcon A toric lens

Device: samfilcon A toric lens

samfilcon A toric lens

Active Comparator group

Description:

Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.

Treatment:

Device: comfilcon A toric lens

Device: samfilcon A toric lens