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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494545
• Other study ID #: P-347-C-016
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: July 12, 2013
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 44 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Delefilcon A contact lens
Silicone hydrogel contact lens CE-marked for single use, daily disposable wear

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No