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

Primary Purpose

Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Dailies Aquacomfort Plus Toric

1-Day Acuvue Moist for Astigmatism

MyDay Toric

About this trial

This is an interventional other trial for Astigmatism

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

CCLR, University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

MyDay Toric

1-Day Acuvue Moist for Astigmatism

Dailies Aquacomfort Plus Toric

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Comfort

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

Dryness

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

Visual Quality

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03134248

First Posted

April 12, 2017

Last Updated

August 27, 2019

Sponsor

Coopervision, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03134248

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 19, 2016 (Actual)

Primary Completion Date

April 12, 2017 (Actual)

Study Completion Date

April 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Astigmatism

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MyDay Toric

Arm Type

Experimental

Arm Description

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

Arm Title

1-Day Acuvue Moist for Astigmatism

Arm Type

Active Comparator

Arm 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

Arm Title

Dailies Aquacomfort Plus Toric

Arm Type

Active Comparator

Arm 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

Intervention Type

Device

Intervention Name(s)

Dailies Aquacomfort Plus Toric

Other Intervention Name(s)

DACP

Intervention Description

daily disposable contact lens

Intervention Type

Device

Intervention Name(s)

1-Day Acuvue Moist for Astigmatism

Other Intervention Name(s)

1-Day AM

Intervention Description

daily disposable contact lens

Intervention Type

Device

Intervention Name(s)

MyDay Toric

Other Intervention Name(s)

MDT

Intervention Description

daily disposable contact lens

Primary Outcome Measure Information:

Title

Comfort

Description

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

Time Frame

1 week

Title

Dryness

Description

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

Time Frame

1 week

Title

Visual Quality

Description

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

Time Frame

1 week

Title

Lens Preference With Respect to Overall Comfort

Description

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

Time Frame

1 week

Title

Lens Preference With Respect to Visual Quality

Description

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

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

CCLR, University of Waterloo

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2L 3G1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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