Performance Assessment of a Modified Daily Disposable Contact Lens

The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia; Hyperopia
• Intervention / Treatment: Device: Modified delefilcon A contact lenses; Device: Delefilcon A contact lenses

Detailed Description

The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Alcon Investigative Site
    • Orlando, Florida, United States, 32803
      • Alcon Investigative Site
    • West Palm Beach, Florida, United States, 33405
      • Alcon Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Alcon Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;
• Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
• Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
• Monocular (only one eye with functional vision);
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: MDACL, then DACL; Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.	Device: Modified delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: MDACL; Device: Delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: DACL
OTHER: DACL, then MDACL; DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.	Device: Modified delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: MDACL; Device: Delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: DACL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Contrast Distance Visual Acuity (logMAR)	Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.	Day 1 Dispense, Day 7 Follow-Up

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. CDMA Project Lead, Vision Care, Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2018
• Primary Completion (ACTUAL): January 7, 2019
• Study Completion (ACTUAL): January 7, 2019

Study Registration Dates

• First Submitted: December 1, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (ACTUAL): December 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Contact lens; Visual acuity; Vision correction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CLP691-C002

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.: No