Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

• ClinicalTrials.gov Identifier: NCT03095027
• Recruitment Status: Completed
• First Posted: March 29, 2017
• Results First Posted: February 4, 2019
• Last Update Posted: February 4, 2019
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Refractive Error	Device: FID122819 contact lenses; Device: Stenfilcon A contact lenses	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Alcon Observer and Sponsor personnel were also masked.
• Primary Purpose: Treatment
• Official Title: Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
• Actual Study Start Date: April 19, 2017
• Actual Primary Completion Date: May 15, 2017
• Actual Study Completion Date: May 15, 2017

Arms and Interventions

Arm	Intervention/treatment
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 Name: MyDay®
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 Name: MyDay®

Outcome Measures

Primary Outcome Measures :

1. Visual Acuity (VA) [ Time Frame: Baseline/Dispense (Day 1), Week 1, each product ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Alcon Investigative Site

Longwood, Florida, United States, 32779

Alcon Investigative Site

Maitland, Florida, United States, 32751

United States, Georgia

Alcon Investigative Site

Johns Creek, Georgia, United States, 30097

Sponsors and Collaborators

Alcon Research

Investigators

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

  Study Documents (Full-Text)

Documents provided by Alcon Research:

Study Protocol  [PDF] March 7, 2017

Statistical Analysis Plan  [PDF] March 21, 2017

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03095027
• Other Study ID Numbers: CLE383-C003
• First Posted: March 29, 2017
• Results First Posted: February 4, 2019
• Last Update Posted: February 4, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Alcon Research:

contact lens, silicone hydrogel, daily disposable, visual acuity

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases