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

NCT01494545 | Completed Results

• 1 other identifier: P-347-C-016
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myopia

Keywords

DAILIES TOTAL1; Alcon; contact lens

Outcome Measures

Primary Outcomes (21)

• Initial Comfort

  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.

  Day 1

• Comfort at Insertion by Visit

  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.

  Day 7, Day 14

• Comfort During the Day by Visit

  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.

  Day 7, Day 14

• Comfort at End of Day by Visit

  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.

  Day 7, Day 14

• Overall Comfort by Visit

  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.

  Day 7, Day 14

• Initial Quality of Vision

  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.

  Day 1

• Quality of Vision at Insertion by Visit

  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.

  Day 7, Day 14

• Quality of Vision During the Day by Visit

  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.

  Day 7, Day 14

• Quality of Vision at End of Day by Visit

  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.

  Day 7, Day 14

• Overall Quality of Vision by Visit

  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.

  Day 7, Day 14

• Average Comfortable Daily Wear Time by Visit

  Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.

  Day 7, Day 14

• Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.

  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.

  Day 14

• Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.

  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.

  Day 14

• Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.

  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.

  Day 14

• Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.

  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.

  Day 14

• Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.

  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.

  Day 14

• Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.

  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.

  Day 14

• Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.

  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.

  Day 14

• Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.

  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.

  Day 14

• Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:

  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.

  Day 14

• Likert Statement: I am Interested in Purchasing These Contact Lenses.

  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.

  Day 14

Secondary Outcomes (7)

• Lens Surface Characteristics: Dry Areas/Non-wetting

  Day 1

• Lens Surface Characteristics: Dry Areas/Non-Wetting

  Day 7

• Lens Surface Characteristics: Dry Areas/Non-Wetting

  Day 14

• Duration of Overall Training Time

  Day 1

• Investigator's Satisfaction With Lens Fit by Visit

  Day 1, Day 7, Day 14

Study Arms (1)

Delefilcon A

EXPERIMENTAL

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

Interventions

Delefilcon A contact lens DEVICE

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

Also known as: DAILIES® TOTAL1™

Delefilcon A

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jami Kern, PhD
• Organization: Alcon Research, Ltd

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Jami Kern, PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 19, 2013
• Results First Posted: June 25, 2013

Record last verified: 2013-07