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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lens

• Registration Number: NCT01494545
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2013-05-01
• Results First Submitted QC: 2013-05-01
• Results First Posted: 2013-06-25
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delefilcon A	Delefilcon A contact lens	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.

Primary Outcome Measures

Name	Time	Method
Initial Comfort	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	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	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	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	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	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	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	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	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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:	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.	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 Outcome Measures

Name	Time	Method
Lens Surface Characteristics: Dry Areas/Non-wetting	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	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	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	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	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	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.