Clinical Comparison of Two Daily Disposable Soft Contact Lenses

The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia
• Intervention / Treatment: Device: verofilcon A contact lenses; Device: somofilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • 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:

• Understand and sign an Informed Consent Form;
• Successful wear of daily disposable 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;
• Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
• Willing to stop wearing habitual contact lenses for the duration of study participation;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
• Refractive, ocular, or intraocular surgery, as specified in the protocol;
• Eye condition or injury, as specified in the protocol;
• Current or history of 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;
• Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
• Currently wearing clariti® 1 day contact lenses;
• Habitually wearing monovision or multifocal lenses during the last 3 months;
• 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: DD T2, then Clariti 1 Day; Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.	Device: verofilcon A contact lenses; Investigational daily disposable soft contact lenses; Other Names: DD T2; Device: somofilcon A contact lenses; Commercially available daily disposable soft contact lenses; Other Names: clariti® 1 day; Clariti 1 Day
Other: Clariti 1 Day, then DD T2; Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.	Device: verofilcon A contact lenses; Investigational daily disposable soft contact lenses; Other Names: DD T2; Device: somofilcon A contact lenses; Commercially available daily disposable soft contact lenses; Other Names: clariti® 1 day; Clariti 1 Day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Quality of Vision	Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.	Day 8, each product

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): June 11, 2018
• Study Completion (Actual): June 11, 2018

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: vision; soft contact lenses; eyesight
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE383-C006

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