Comparison of Two Daily Disposable Lenses

Not Applicable

Completed

• Conditions: Myopia; Refractive Ametropia

• Registration Number: NCT04013789
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

Detailed Description

Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Study Start: 2019-08-27
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Results First Submitted: 2020-10-19
• Results First Submitted QC: 2020-10-19
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Results First Posted: 2020-11-10
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• At least 3 months of soft contact lens wearing experience;
• Wears habitual lenses at least 5 days per week and at least 8 hours per day;
• Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;
• Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;
• Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Routinely sleeps in contact lenses;
• Known pregnancy at time of enrollment;
• Binocular vision issues or issues of eye alignment;
• Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;
• Use of medications as specified in the protocol;
• Ocular surgery within the past 12 months;
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Mean Distance Visual Acuity (VA) With Study Lenses	Week 1, each product	VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Bloomington, Indiana, United States