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

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ClinicalTrials.gov Identifier: NCT01494545
Recruitment Status : Completed
First Posted : December 19, 2011
Results First Posted : June 25, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE December 15, 2011
First Posted Date  ICMJE December 19, 2011
Results First Submitted Date  ICMJE May 1, 2013
Results First Posted Date  ICMJE June 25, 2013
Last Update Posted Date July 19, 2013
Study Start Date  ICMJE December 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
  • Initial Comfort [ Time Frame: Day 1 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
Comfort Upon Insertion [ Time Frame: Two weeks, replacing lenses daily ]
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 2 weeks of wear time. Comfort upon insertion will be evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Change History Complete list of historical versions of study NCT01494545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
  • Lens Surface Characteristics: Dry Areas/Non-wetting [ Time Frame: Day 1 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
Official Title  ICMJE Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
Brief Summary The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE Device: Delefilcon A contact lens
Silicone hydrogel contact lens CE-marked for single use, daily disposable wear
Other Name: DAILIES® TOTAL1™
Study Arms  ICMJE 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.
Intervention: Device: Delefilcon A contact lens
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2012)
102
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2011)
100
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01494545
Other Study ID Numbers  ICMJE P-347-C-016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jami Kern, PhD Alcon Research
PRS Account Alcon Research
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP