Clinical trial NCT03134248: Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses
Official title: Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses

Detailed description: Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses

Eligibility criteria: Inclusion Criteria:

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;
6. Is willing to wear contact lens in both eyes for the duration of the study;
7. Has a minimum spectacle astigmatism of - 0.75;
8. Can be fit with the three study contact lens types in the powers available;
9. Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity);
10. Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses.
11. Has clear corneas and no active\* ocular disease;

    * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Exclusion Criteria:

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 outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
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.

Primary outcomes:
measure: Comfort
timeFrame: 1 week
measure: Dryness
timeFrame: 1 week
measure: Visual Quality
timeFrame: 1 week
measure: Lens Preference With Respect to Overall Comfort
timeFrame: 1 week
measure: Lens Preference With Respect to Visual Quality
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: CCLR, University of Waterloo
state: Ontario
Study officials:
References: