Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: FID122819 contact lenses; Device: Stenfilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Longwood, Florida, United States, 32779
      • Alcon Investigative Site
    • Maitland, Florida, United States, 32751
      • Alcon Investigative Site
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • 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 IRB-approved Informed Consent Form;
• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
• Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
• Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, abnormality or disease (including systemic) 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 refractive surgery or plan to have refractive surgery during the study;
• Ocular or intraocular surgery within the previous 12 months or planned during the study;
• Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
• Any previous or current wear of MYDAY;
• Habitually wearing monovision or multifocal lenses during the last 3 months;
• Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Other protocol-defined 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: FID122819, then stenfilcon A; FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week	Device: FID122819 contact lenses; Investigational spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: DDT2; Verofilcon A; Device: Stenfilcon A contact lenses; Commercially available spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: MyDay®
Other: Stenfilcon A, then FID122819; Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week	Device: FID122819 contact lenses; Investigational spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: DDT2; Verofilcon A; Device: Stenfilcon A contact lenses; Commercially available spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: MyDay®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity (VA)	VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.	Baseline/Dispense (Day 1), Week 1, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Manager, Trial Management Operations, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: contact lens, silicone hydrogel, daily disposable, visual acuity
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-C003

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