Comparison of Two Daily Disposable Lenses

Not Applicable

Completed

• Conditions: Myopia; Refractive Ametropia
• Interventions: Device: DACP FreshTech contact lenses; Device: DACP contact lenses

• 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

Arm && Interventions

Group	Intervention	Description
DACP FreshTech, then DACP	DACP FreshTech contact lenses	DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.
DACP, then DACP FreshTech	DACP FreshTech contact lenses	DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.
DACP, then DACP FreshTech	DACP contact lenses	DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.
DACP FreshTech, then DACP	DACP contact lenses	DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.

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