N/A Completed N=102 Treatment

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

Myopia

Source: ClinicalTrials.gov NCT01494545 ↗

Enrolled (actual)

102

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcomePrimary: Initial Comfort — 8.6 Units on a scale

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Initial Comfort	8.6	—
PRIMARY Comfort at Insertion by Visit	8.6; 8.8	—
PRIMARY Comfort During the Day by Visit	8.7; 8.9	—
PRIMARY Comfort at End of Day by Visit	7.5; 7.9	—
PRIMARY Overall Comfort by Visit	8.5; 8.7	—
PRIMARY Initial Quality of Vision	8.7	—
PRIMARY Quality of Vision at Insertion by Visit	8.7; 9.0	—
PRIMARY Quality of Vision During the Day by Visit	8.9; 8.9	—
PRIMARY Quality of Vision at End of Day by Visit	8.3; 8.3	—
PRIMARY Overall Quality of Vision by Visit	8.8; 8.8	—
PRIMARY Average Comfortable Daily Wear Time by Visit	10.3; 10.4	—
PRIMARY Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.	17.4; 43.5; 37.0; 2.2	—
PRIMARY Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.	19.8; 68.1; 12.1; 0.0	—
PRIMARY Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.	18.5; 45.7; 33.7; 2.2	—
PRIMARY Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.	45.7; 47.8; 5.4; 1.1	—
PRIMARY Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.	41.3; 54.3; 4.3; 0.0	—
PRIMARY Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.	22.8; 44.6; 30.4; 2.2	—
PRIMARY Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.	9.8; 35.9; 50.0; 4.3	—
PRIMARY Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.	46.7; 45.7; 7.6; 0.0	—
PRIMARY Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:	21.7; 41.3; 22.8; 14.1; 0.0	—
PRIMARY Likert Statement: I am Interested in Purchasing These Contact Lenses.	28.3; 64.1; 7.6; 0.0	—
SECONDARY Lens Surface Characteristics: Dry Areas/Non-wetting	77.2; 76.1; 76.6; 19.6; 23.9; 21.7	—
SECONDARY Duration of Overall Training Time	6.926; 6.806	—
SECONDARY Investigator's Satisfaction With Lens Fit by Visit	9.2; 9.3; 9.3	—
SECONDARY Investigator's Overall Impression of Surface Wettability by Visit	9.3; 9.3; 9.3	—
SECONDARY Investigator's Rating of Ease of Fit	75.0; 22.8; 2.2; 0.0	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01494545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.