Clinical trial NCT01494545: Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
Official title: Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: DAILIES TOTAL1
Alcon
contact lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Initial Comfort
timeFrame: Day 1
measure: Comfort at Insertion by Visit
timeFrame: Day 7, Day 14
measure: Comfort During the Day by Visit
timeFrame: Day 7, Day 14
measure: Comfort at End of Day by Visit
timeFrame: Day 7, Day 14
measure: Overall Comfort by Visit
timeFrame: Day 7, Day 14
measure: Initial Quality of Vision
timeFrame: Day 1
measure: Quality of Vision at Insertion by Visit
timeFrame: Day 7, Day 14
measure: Quality of Vision During the Day by Visit
timeFrame: Day 7, Day 14
measure: Quality of Vision at End of Day by Visit
timeFrame: Day 7, Day 14
measure: Overall Quality of Vision by Visit
timeFrame: Day 7, Day 14
measure: Average Comfortable Daily Wear Time by Visit
timeFrame: Day 7, Day 14
measure: Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.
timeFrame: Day 14
measure: Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.
timeFrame: Day 14
measure: Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.
timeFrame: Day 14
measure: Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.
timeFrame: Day 14
measure: Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.
timeFrame: Day 14
measure: Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.
timeFrame: Day 14
measure: Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.
timeFrame: Day 14
measure: Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.
timeFrame: Day 14
measure: Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:
timeFrame: Day 14
measure: Likert Statement: I am Interested in Purchasing These Contact Lenses.
timeFrame: Day 14
Secondary outcomes:
measure: Lens Surface Characteristics: Dry Areas/Non-wetting
timeFrame: Day 1
measure: Lens Surface Characteristics: Dry Areas/Non-Wetting
timeFrame: Day 7
measure: Lens Surface Characteristics: Dry Areas/Non-Wetting
timeFrame: Day 14
measure: Duration of Overall Training Time
timeFrame: Day 1
measure: Investigator's Satisfaction With Lens Fit by Visit
timeFrame: Day 1, Day 7, Day 14
measure: Investigator's Overall Impression of Surface Wettability by Visit
timeFrame: Day 1, Day 7, Day 14
measure: Investigator's Rating of Ease of Fit
timeFrame: Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jami Kern, PhD
role: STUDY_DIRECTOR
References: