Clinical Performance of Two Daily Disposable Contact Lenses - Study 1

The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Verofilcon A contact lenses; Device: Etafilcon A contact lenses

Detailed Description

The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany, 07745
    • Alcon Investigative Site

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:

• Able to understand and sign an approved Informed Consent form
• Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
• Best corrected VA of logMAR 0.10 or better in each eye
• Willing to discontinue artificial tears and rewetting drops during the study
• Able to wear contact lenses within the protocol-specified sphere power range
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
• History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
• 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
• Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Verofilcon A contact lens in the right eye (OD), with etafilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.	Device: Verofilcon A contact lenses; Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Precision1™; Device: Etafilcon A contact lenses; Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Acuvue® Moist
Active Comparator: Sequence 2; Etafilcon A contact lens in the right eye (OD), with verofilcon A contact lens in the left eye (OS), as randomized. Lenses will be worn for one day, approximately 8 hours.	Device: Verofilcon A contact lenses; Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Precision1™; Device: Etafilcon A contact lenses; Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia); Other Names: Acuvue® Moist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of day (EOD) visual acuity at distance	Visual acuity (VA) will be measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity.	Day 1, after 8 hours of wear

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): August 5, 2019
• Study Completion (Actual): August 5, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Contact lens; Visual acuity; Vision correction; Daily disposable contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-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: No
• product manufactured in and exported from the U.S.: No