The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Silicone hydrogel contact lens CE-marked for single use, daily disposable wear
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 14
Lens Surface Characteristics: Dry Areas/Non-wetting
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
Lens Surface Characteristics: Dry Areas/Non-Wetting
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
Lens Surface Characteristics: Dry Areas/Non-Wetting
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
Duration of Overall Training Time
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
Investigator's Satisfaction With Lens Fit by Visit
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
Investigator's Overall Impression of Surface Wettability by Visit
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
Investigator's Rating of Ease of Fit
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