Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

NCT04980456 | Completed Results FDA Device

• 1 other identifier: CLY935-C019
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Conditions

Myopia

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Distance VA (logMAR) With Study Lenses

  Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

  Day 30, each study product

Study Arms (2)

TOTAL30, then Biofinity

OTHER

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE

Biofinity, then TOTAL30

OTHER

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE

Interventions

Lehfilcon A contact lenses DEVICE

Investigational silicone hydrogel contact lenses

Also known as: TOTAL30

Biofinity, then TOTAL30; TOTAL30, then Biofinity

Comfilcon A contact lenses DEVICE

Commercially available silicone hydrogel contact lenses

Also known as: CooperVision® Biofinity®, Biofinity

Biofinity, then TOTAL30; TOTAL30, then Biofinity

CLEAR CARE DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Biofinity, then TOTAL30; TOTAL30, then Biofinity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and sign an approved Informed Consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
• Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
• Willing to stop wearing habitual contact lenses for the duration of study participation.

You may not qualify if:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
• Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
• Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
• Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
• Current or prior Biofinity contact lens wear in the past 3 months prior to consent.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (14)

Alcon Investigator 8135

Los Angeles, California, 90012, United States

Location

Alcon Investigator 8062

Oakland, California, 94607, United States

Location

Alcon Investigator 8106

San Francisco, California, 94127, United States

Location

Alcon Investigator 6356

Longwood, Florida, 32779, United States

Location

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6654

West Palm Beach, Florida, 33405, United States

Location

Alcon Investigator 6567

Pittsburg, Kansas, 66762, United States

Location

Alcon Investigator 5582

Louisville, Kentucky, 40206, United States

Location

Alcon Investigator 8097

Sterling Heights, Michigan, 48312, United States

Location

Alcon Investigator 7980

Willmar, Minnesota, 56201, United States

Location

Alcon Investigator 8130

New York, New York, 10036, United States

Location

Alcon Investigator 6401

Warwick, Rhode Island, 02888, United States

Location

Alcon Investigator 6353

Memphis, Tennessee, 38111, United States

Location

Alcon Investigator 8175

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: CDMA Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 28, 2021
• Study Start: August 5, 2021
• Primary Completion: November 20, 2021
• Study Completion: November 20, 2021
• Last Updated: January 6, 2023
• Results First Posted: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)