Clinical Validation of DACP Digital Design

The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Nelfilcon A digital contact lenses; Device: Nelfilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Alcon Investigative Site
  • Ohio
    • Powell, Ohio, United States, 43065
      • Alcon Investigative Site
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Alcon Investigative Site
    • Memphis, Tennessee, United States, 38104
      • Alcon Investigative Site
    • Memphis, Tennessee, United States, 38111
      • 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:

• Willing and able to sign an IRB/IEC approved Informed Consent form;
• Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
• Experiencing symptoms of eye strain from using technology;
• Willing to wear study lenses each day;
• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
• Willing to NOT use rewetting/lubricating drops at any time during the study;
• Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
• Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Exclusion Criteria:

• Conditions, use of medications, injury, or surgery, as specified in the protocol;
• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
• Monocular (only one eye with functional vision);
• Pregnant.

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 Digital then DACP; Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality.	Device: Nelfilcon A digital contact lenses; Silicone hydrogel digital contact lenses; Other Names: DAILIES® AquaComfort Plus® Digital; DACP Digital; Device: Nelfilcon A contact lenses; Silicone hydrogel spherical contact lenses; Other Names: DAILIES® AquaComfort Plus®; DACP
Other: DACP then DACP Digital; Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality.	Device: Nelfilcon A digital contact lenses; Silicone hydrogel digital contact lenses; Other Names: DAILIES® AquaComfort Plus® Digital; DACP Digital; Device: Nelfilcon A contact lenses; Silicone hydrogel spherical contact lenses; Other Names: DAILIES® AquaComfort Plus®; DACP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity (VA) (logMAR, OU)	VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.	Day 7, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Vision	Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.	Day 7, each product

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): August 26, 2018
• Study Completion (Actual): August 26, 2018

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLD523-C001

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
• product manufactured in and exported from the U.S.: Yes