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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014