Two Daily Disposable Contact Lenses in Symptomatic Patients

The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Delefilcon A contact lenses; Device: Senofilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Alcon Investigative Site
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Alcon Investigative Site
  • Ohio
    • Powell, Ohio, United States, 43065
      • Alcon Investigative Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to understand and must sign an IRB-approved informed consent form;
• Soft contact lens wearers in both eyes during the past 3 months;
• Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
• Willing to wear study lenses at least 3 days per week and at least 8 hours per day;
• Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria:

• Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;
• Intolerance, hypersensitivity, or allergy to any component of the study products;
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOTAL1; Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality	Device: Delefilcon A contact lenses; Water Gradient silicon hydrogel daily disposable contact lenses; Other Names: DAILIES TOTAL1® (DT1)
Active Comparator: 1-DAY; Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality	Device: Senofilcon A contact lenses; Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology; Other Names: ACUVUE OASYS® 1-DAY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Corrected Distance Visual Acuity (VA)	Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.	Week 4

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): September 25, 2018

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Symptomatic
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CLS312-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
• product manufactured in and exported from the U.S.: No