Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01494545
First received: December 15, 2011
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.


Condition Intervention
Myopia
Device: Delefilcon A contact lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Initial Comfort [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Comfort at Insertion by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Comfort During the Day by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Comfort at End of Day by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Overall Comfort by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Initial Quality of Vision [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Quality of Vision at Insertion by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Quality of Vision During the Day by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Quality of Vision at End of Day by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Overall Quality of Vision by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.

  • Average Comfortable Daily Wear Time by Visit [ Time Frame: Day 7, Day 14 ] [ Designated as safety issue: No ]
    Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.

  • Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

  • Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

  • Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

  • Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

  • Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

  • Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

  • Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.

  • Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.

  • Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is: [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.

  • Likert Statement: I am Interested in Purchasing These Contact Lenses. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.


Secondary Outcome Measures:
  • Lens Surface Characteristics: Dry Areas/Non-wetting [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).

  • Lens Surface Characteristics: Dry Areas/Non-Wetting [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).

  • Lens Surface Characteristics: Dry Areas/Non-Wetting [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).

  • Duration of Overall Training Time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.

  • Investigator's Satisfaction With Lens Fit by Visit [ Time Frame: Day 1, Day 7, Day 14 ] [ Designated as safety issue: No ]
    The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.

  • Investigator's Overall Impression of Surface Wettability by Visit [ Time Frame: Day 1, Day 7, Day 14 ] [ Designated as safety issue: No ]
    The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).

  • Investigator's Rating of Ease of Fit [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    The investigator indicated agreement/disagreement with the statement, "The study lenses were easy to fit for this subject," by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree.


Enrollment: 102
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delefilcon A
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
Device: Delefilcon A contact lens
Silicone hydrogel contact lens CE-marked for single use, daily disposable wear
Other Name: DAILIES® TOTAL1™

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign Informed Consent.
  • No previous contact lens experience or attempt to try contact lenses (neophyte).
  • Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
  • Use spectacle lenses for vision correction.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • 45 years or older.
  • Prior wear experience with rigid or soft contact lenses.
  • Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
  • History of ocular surgery/trauma within the last six months.
  • Pregnant or nursing women.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494545

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami Kern, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01494545     History of Changes
Other Study ID Numbers: P-347-C-016
Study First Received: December 15, 2011
Results First Received: May 1, 2013
Last Updated: July 12, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Alcon Research:
DAILIES TOTAL1
Alcon
contact lens

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014