Clinical trial NCT03684928: A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses
Official title: A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism Bilateral
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ease of Insertion(Handling)
timeFrame: Baseline
measure: Ease of Insertion (Handling)
timeFrame: 2 weeks
measure: Ease of Insertion(Handling)
timeFrame: 1 month
Secondary outcomes:
measure: Rotational Recovery After Lens Mislocation
timeFrame: Baseline
measure: Rotational Recovery After Lens Mislocation
timeFrame: 1 month
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University Of Waterloo
state: Ontario
Study officials:
affiliation: Director, Centre for Ocular Research and Education
name: Lyndon Jones, PhD FCOptom
role: PRINCIPAL_INVESTIGATOR
References: