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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.

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

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Delefilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delefilcon A<br>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<br>* Silicone hydrogel contact lens CE-marked for single use, daily disposable wear<br>* Other names: DAILIES® TOTAL1™;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | 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. | 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). | 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. | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DAILIES TOTAL1, Alcon, contact lens