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

NCT ID: NCT03134248

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-19
• Study Completion Date: 2017-04-12

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

Conditions

Astigmatism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

MyDay Toric

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

Group Type: EXPERIMENTAL

MyDay Toric

Intervention Type: DEVICE

daily disposable contact lens

1-Day Acuvue Moist for Astigmatism

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

Group Type: ACTIVE_COMPARATOR

1-Day Acuvue Moist for Astigmatism

Intervention Type: DEVICE

daily disposable contact lens

Dailies Aquacomfort Plus Toric

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

Group Type: ACTIVE_COMPARATOR

Dailies Aquacomfort Plus Toric

Intervention Type: DEVICE

daily disposable contact lens

Interventions

Dailies Aquacomfort Plus Toric

daily disposable contact lens

Intervention Type: DEVICE

1-Day Acuvue Moist for Astigmatism

daily disposable contact lens

Intervention Type: DEVICE

MyDay Toric

daily disposable contact lens

Intervention Type: DEVICE

Other Intervention Names

DACP; 1-Day AM; MDT

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CCLR, University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-72

Identifier Type: -

Identifier Source: org_study_id