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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Myopia
Intervention Device: Delefilcon A contact lens
Enrollment 102
Recruitment Details Participants were recruited from study centers in Europe.
Pre-assignment Details This reporting group includes all enrolled participants.
Arm/Group Title Delefilcon A
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 102
Completed 92
Not Completed 10
Arm/Group Title Delefilcon A
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 98
Hide Baseline Analysis Population Description
This reporting group includes all enrolled participants who were dispensed study product.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
24.8  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
49
  50.0%
Male
49
  50.0%
1.Primary Outcome
Title Initial Comfort
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.6  (1.3)
2.Primary Outcome
Title Comfort at Insertion by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 8.6  (1.3)
Day 14 8.8  (1.2)
3.Primary Outcome
Title Comfort During the Day by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 8.7  (1.3)
Day 14 8.9  (1.0)
4.Primary Outcome
Title Comfort at End of Day by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 7.5  (1.8)
Day 14 7.9  (1.5)
5.Primary Outcome
Title Overall Comfort by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 8.5  (1.2)
Day 14 8.7  (1.0)
6.Primary Outcome
Title Initial Quality of Vision
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.7  (1.1)
7.Primary Outcome
Title Quality of Vision at Insertion by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 8.7  (1.2)
Day 14 9.0  (1.2)
8.Primary Outcome
Title Quality of Vision During the Day by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 8.9  (1.2)
Day 14 8.9  (1.1)
9.Primary Outcome
Title Quality of Vision at End of Day by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 8.3  (1.5)
Day 14 8.3  (1.4)
10.Primary Outcome
Title Overall Quality of Vision by Visit
Hide Description 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.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 7 8.8  (1.1)
Day 14 8.8  (1.1)
11.Primary Outcome
Title Average Comfortable Daily Wear Time by Visit
Hide Description Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.
Time Frame Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Median (Standard Deviation)
Unit of Measure: Hours
Day 7 10.3  (3.2)
Day 14 10.4  (2.8)
12.Primary Outcome
Title Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 17.4
Agree 43.5
Disagree 37.0
Strongly Disagree 2.2
13.Primary Outcome
Title Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 19.8
Agree 68.1
Disagree 12.1
Strongly Disagree 0.0
14.Primary Outcome
Title Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 18.5
Agree 45.7
Disagree 33.7
Strongly Disagree 2.2
15.Primary Outcome
Title Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 45.7
Agree 47.8
Disagree 5.4
Strongly Disagree 1.1
16.Primary Outcome
Title Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 41.3
Agree 54.3
Disagree 4.3
Strongly Disagree 0.0
17.Primary Outcome
Title Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 22.8
Agree 44.6
Disagree 30.4
Strongly Disagree 2.2
18.Primary Outcome
Title Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 9.8
Agree 35.9
Disagree 50.0
Strongly Disagree 4.3
19.Primary Outcome
Title Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 46.7
Agree 45.7
Disagree 7.6
Strongly Disagree 0.0
20.Primary Outcome
Title Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Much Better 21.7
A Little Better 41.3
Same 22.8
A Little Worse 14.1
Much Worse 0.0
21.Primary Outcome
Title Likert Statement: I am Interested in Purchasing These Contact Lenses.
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Very Interested 28.3
Interested 64.1
Not Interested 7.6
Very Disinterested 0.0
22.Secondary Outcome
Title Lens Surface Characteristics: Dry Areas/Non-wetting
Hide Description 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).
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A, Right Eye Delefilcon A, Left Eye Delefilcon A, Both Eyes
Hide Arm/Group Description:
Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
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.
Overall Number of Participants Analyzed 92 92 92
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
92 92 184
Measure Type: Number
Unit of Measure: Percentage of eyes
None 85.9 81.5 83.7
Very Slight 13.0 15.2 14.1
Slight 1.1 3.3 2.2
Moderate 0.0 0.0 0.0
Severe 0.0 0.0 0.0
23.Secondary Outcome
Title Lens Surface Characteristics: Dry Areas/Non-Wetting
Hide Description 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).
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A, Right Eye Delefilcon A, Left Eye Delefilcon A, Both Eyes
Hide Arm/Group Description:
Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
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.
Overall Number of Participants Analyzed 92 92 92
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
92 92 184
Measure Type: Number
Unit of Measure: Percentage of eyes
None 81.1 82.2 81.7
Very Slight 15.6 15.6 15.6
Slight 3.3 2.2 2.8
Moderate 0.0 0.0 0.0
Severe 0.0 0.0 0.0
24.Secondary Outcome
Title Lens Surface Characteristics: Dry Areas/Non-Wetting
Hide Description 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).
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A, Right Eye Delefilcon A, Left Eye Delefilcon A, Both Eyes
Hide Arm/Group Description:
Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
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.
Overall Number of Participants Analyzed 92 92 92
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
92 92 184
Measure Type: Number
Unit of Measure: Percentage of eyes
None 77.2 76.1 76.6
Very Slight 19.6 23.9 21.7
Slight 3.3 0.0 1.6
Moderate 0.0 0.0 0.0
Severe 0.0 0.0 0.0
25.Secondary Outcome
Title Duration of Overall Training Time
Hide Description The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Minutes
Insertion time 6.926  (6.558)
Removal time 6.806  (7.872)
26.Secondary Outcome
Title Investigator's Satisfaction With Lens Fit by Visit
Hide Description 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.
Time Frame Day 1, Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1 9.2  (0.9)
Day 7 9.3  (0.9)
Day 14 9.3  (0.8)
27.Secondary Outcome
Title Investigator's Overall Impression of Surface Wettability by Visit
Hide Description 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).
Time Frame Day 1, Day 7, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1 9.3  (0.9)
Day 7 9.3  (1.0)
Day 14 9.3  (1.0)
28.Secondary Outcome
Title Investigator's Rating of Ease of Fit
Hide Description 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.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.
Arm/Group Title Delefilcon A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Percentage of participants
Strongly Agree 75.0
Agree 22.8
Disagree 2.2
Strongly Disagree 0.0
Time Frame Adverse events were collected for the duration of the study from informed consent signature until last follow-up visit.
Adverse Event Reporting Description This reporting group includes all enrolled participants who were dispensed study product.
 
Arm/Group Title Delefilcon A
Hide Arm/Group Description 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.
All-Cause Mortality
Delefilcon A
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Delefilcon A
Affected / at Risk (%)
Total   0/98 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Delefilcon A
Affected / at Risk (%)
Total   0/98 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jami Kern, PhD
Organization: Alcon Research, Ltd
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01494545     History of Changes
Other Study ID Numbers: P-347-C-016
First Submitted: December 15, 2011
First Posted: December 19, 2011
Results First Submitted: May 1, 2013
Results First Posted: June 25, 2013
Last Update Posted: July 19, 2013