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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: MyDay Toric; Device: 1-Day Acuvue Moist for Astigmatism; Device: Dailies Aquacomfort Plus Toric

• Registration Number: NCT03134248
• Lead Sponsor: Coopervision, Inc.

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

Study Timeline

• Study Start: 2016-10-19
• Primary Completion: 2017-04-12
• Study Completion: 2017-04-12
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-04-28
• Results First Submitted: 2018-05-14
• Results First Submitted QC: 2018-06-21
• Results First Posted: 2018-06-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MyDay Toric	MyDay Toric	Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study
1-Day Acuvue Moist for Astigmatism	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
Dailies Aquacomfort Plus Toric	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

Primary Outcome Measures

Name	Time	Method
Dryness	1 week	Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
Visual Quality	1 week	Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
Comfort	1 week	Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Lens Preference With Respect to Overall Comfort	1 week	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
Lens Preference With Respect to Visual Quality	1 week	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

Trial Locations

Locations (1)

CCLR, University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada