Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: MyDay Toric; Device: 1-Day Acuvue Moist for Astigmatism; Device: Dailies Aquacomfort Plus Toric

Study type: Interventional

Funder types: Industry

Identifiers

NCT03134248

EX-MKTG-72

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 3 patient groups

MyDay Toric

Experimental group

Description:

Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study

Treatment:

Device: MyDay Toric

1-Day Acuvue Moist for Astigmatism

Active Comparator group

Description:

Participants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study

Treatment:

Device: 1-Day Acuvue Moist for Astigmatism

Dailies Aquacomfort Plus Toric

Active Comparator group

Description:

Participants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study

Treatment:

Device: Dailies Aquacomfort Plus Toric