ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must sign informed consent form;
• Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
• Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
• Cylinder equal or lower than -0.75D in both eyes;
• Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
• Can be successfully fitted with both study lenses at Visit 1;
• Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Fitted with monovision;
• Prior refractive surgery;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pregnant or lactating;
• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
• Participation in any clinical study within 30 days of Visit 1;
• Current DT1 or AO1D lens wearer;
• 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: DT1, then AO1D; Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.	Device: Delefilcon A contact lenses; Other Names: DAILIES TOTAL1® (DT1); Device: Senofilcon A contact lenses; Other Names: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)
Other: AO1D, then DT1; Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.	Device: Delefilcon A contact lenses; Other Names: DAILIES TOTAL1® (DT1); Device: Senofilcon A contact lenses; Other Names: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14	Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.	Day 14, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14	The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.	Day 14, each product

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Sr. Clinical Manager, Global Medical Affairs, GCRA, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2016
• Primary Completion (Actual): August 17, 2016
• Study Completion (Actual): August 17, 2016

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLV771-P001