Comparison of Two Daily Disposable Lenses

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).

Study Overview

• Status: Completed
• Conditions: Myopia; Refractive Ametropia
• Intervention / Treatment: Device: DACP FreshTech contact lenses; Device: DACP contact lenses

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DACP FreshTech, then DACP; 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.	Device: DACP FreshTech contact lenses; Nelfilcon A soft contact lenses with a modified lens design; Other Names: DAILIES® AquaComfort PLUS® FreshTech; Device: DACP contact lenses; Nelfilcon A soft contact lenses; Other Names: DAILIES® AquaComfort PLUS®
Other: DACP, then DACP FreshTech; 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.	Device: DACP FreshTech contact lenses; Nelfilcon A soft contact lenses with a modified lens design; Other Names: DAILIES® AquaComfort PLUS® FreshTech; Device: DACP contact lenses; Nelfilcon A soft contact lenses; Other Names: DAILIES® AquaComfort PLUS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Distance Visual Acuity (VA) With Study Lenses	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.	Week 1, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Project Lead, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: eye strain; eye fatigue
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLD523-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes