Clinical trial NCT03519932: Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses
Official title: A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 49
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comfort at Insertion
timeFrame: Dispense
measure: Comfort
timeFrame: 2 weeks
measure: Comfort
timeFrame: 1-month
measure: Lens Preference Based on Overall Comfort
timeFrame: 1 month
measure: Lens Preference Based on Overall Dryness
timeFrame: 1 month
measure: Dryness
timeFrame: 2 weeks
measure: Dryness
timeFrame: 1-month
Secondary outcomes:
measure: Ease of Insertion
timeFrame: Dispense
measure: Ease of Insertion
timeFrame: 2-weeks
measure: Ease of Insertion
timeFrame: 1-month
measure: Ease of Removal
timeFrame: 2-weeks
measure: Ease of Removal
timeFrame: 1 month
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: Director, Centre for Ocular Research & Education
name: Lyndon Jones, PhD FCOptom
role: PRINCIPAL_INVESTIGATOR
References: