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

NCT03134248 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-72
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (5)

• Comfort

  Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.

  1 week

• Dryness

  Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness

  1 week

• Visual Quality

  Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied

  1 week

• 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

• 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

Study Arms (3)

MyDay Toric

EXPERIMENTAL

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

Device: MyDay Toric

1-Day Acuvue Moist for Astigmatism

ACTIVE COMPARATOR

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

Device: 1-Day Acuvue Moist for Astigmatism

Dailies Aquacomfort Plus Toric

ACTIVE COMPARATOR

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

Device: Dailies Aquacomfort Plus Toric

Interventions

Dailies Aquacomfort Plus Toric DEVICE

daily disposable contact lens

Also known as: DACP

Dailies Aquacomfort Plus Toric

1-Day Acuvue Moist for Astigmatism DEVICE

daily disposable contact lens

Also known as: 1-Day AM

1-Day Acuvue Moist for Astigmatism

MyDay Toric DEVICE

daily disposable contact lens

Also known as: MDT

MyDay Toric

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has had a self-reported oculo-visual examination in the last two years.
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is an adapted soft contact lens wearer;
• Is willing to wear contact lens in both eyes for the duration of the study;
• Has a minimum spectacle astigmatism of - 0.75;
• Can be fit with the three study contact lens types in the powers available;
• 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);
• Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses.
• 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.

You may not qualify if:

• Is participating in any concurrent clinical trial;
• Has any known active\* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Has known sensitivity to fluorescein dye or products to be used in the study;
• 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;
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
• Is aphakic;
• Has undergone refractive error surgery.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

CCLR, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A.Vega OD MSc., FAAO
• Organization: CooperVision

javega@coopervision.com

9256213761

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 28, 2017
• Study Start: October 19, 2016
• Primary Completion: April 12, 2017
• Study Completion: April 12, 2017
• Last Updated: September 12, 2019
• Results First Posted: June 26, 2018

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)