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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134248
• Other study ID #: EX-MKTG-72
• Status: Completed
• Phase: N/A
• Start date: October 19, 2016
• Est. completion date: April 12, 2017

Study information

• Verified date: August 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 12, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Dailies Aquacomfort Plus Toric
daily disposable contact lens
• 1-Day Acuvue Moist for Astigmatism
daily disposable contact lens
• MyDay Toric
daily disposable contact lens

Locations

Country	Name	City	State
Canada	CCLR, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort	Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.	1 week
Primary	Dryness	Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness	1 week
Primary	Visual Quality	Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied	1 week
Primary	Lens Preference With Respect to Overall Comfort	Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference	1 week
Primary	Lens Preference With Respect to Visual Quality	Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference	1 week