Comparison of Two Daily Disposable Lenses

NCT04013789 | Completed Results FDA Device

• 1 other identifier: CLD523-P001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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).

Conditions

Refractive Ametropia; Myopia

Keywords

eye strain; eye fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DACP FreshTech, then DACP

OTHER

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; Device: DACP contact lenses

DACP, then DACP FreshTech

OTHER

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; Device: DACP contact lenses

Interventions

DACP FreshTech contact lenses DEVICE

Nelfilcon A soft contact lenses with a modified lens design

Also known as: DAILIES® AquaComfort PLUS® FreshTech

DACP FreshTech, then DACP; DACP, then DACP FreshTech

DACP contact lenses DEVICE

Nelfilcon A soft contact lenses

Also known as: DAILIES® AquaComfort PLUS®

DACP FreshTech, then DACP; DACP, then DACP FreshTech

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Investigative Site

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Myopia; Asthenopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: CDMA Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Project Lead

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: August 27, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: November 24, 2020
• Results First Posted: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)