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

Not Applicable

Completed

Interventions: Device: comfilcon A toric lens
Device: samfilcon A toric lens

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

Recruitment & Eligibility

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.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lens Preference Based on Overall Comfort	1 month	Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Dryness	1-month	Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Comfort at Insertion	Dispense	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Comfort	1-month	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Lens Preference Based on Overall Dryness	1 month	Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

Secondary Outcome Measures

Name	Time	Method
Ease of Removal	1 month	Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)
Ease of Insertion	1-month	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)