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OpenTrials
Completed

NCT Number: NCT01494545

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

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

delefilcon A contact lens

Device

Silicone hydrogel contact lens CE-marked for single use, daily disposable wear

Other names: DAILIES® TOTAL1™

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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).

  7. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2011
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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