Comparison of Two Daily Disposable Lenses

Alcon

Status: Completed

Conditions: Myopia; Refractive Ametropia

Treatments: Device: DACP contact lenses; Device: DACP FreshTech contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04013789

CLD523-P001

Details and patient eligibility

About

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).

Full description

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

Enrollment: 79 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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79 participants in 2 patient groups

DACP FreshTech, then DACP

Other group

Description:

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.

Treatment:

Device: DACP FreshTech contact lenses

Device: DACP contact lenses

DACP, then DACP FreshTech

Other group

Description:

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.

Treatment:

Device: DACP FreshTech contact lenses

Device: DACP contact lenses