Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

NCT04207749 | Completed Results FDA Device

• 1 other identifier: CLL949-C018
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

Conditions

Refractive Errors; Myopia; Hyperopia

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)

  Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

  Week 1 Follow-Up

Secondary Outcomes (1)

• Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)

  Week 1 Follow-Up, at least 4 hours after lens insertion

Study Arms (2)

LID015385

EXPERIMENTAL

LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.

Device: LID015385 contact lenses; Device: CLEAR CARE

Biofinity

ACTIVE COMPARATOR

Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.

Device: Comfilcon A contact lenses; Device: CLEAR CARE

Interventions

LID015385 contact lenses DEVICE

Investigational soft contact lenses

LID015385

Comfilcon A contact lenses DEVICE

Commercially available soft contact lenses

Also known as: BIOFINITY®

Biofinity

CLEAR CARE DEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Biofinity; LID015385

Eligibility Criteria

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

You may qualify if:

• Understand and sign an IRB/IEC approved Informed Consent form.
• Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.
• Successful wear of frequent replacement, spherical, daily wear 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.
• Manifest cylinder ≤ 0.75 diopter (D) in each eye.
• Best spectacle corrected visual acuity 20/20 or better in each eye.

You may not qualify if:

• 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.
• Monovision contact lens wear.
• Any habitual wear of Biofinity lenses.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (18)

Alcon Investigator 8103

Glendale, Arizona, 85308, United States

Location

Alcon Investigator 8101

Brentwood, California, 94513, United States

Location

Alcon Investigator 8102

Irvine, California, 92618, United States

Location

Alcon Investigator 8135

Los Angeles, California, 90012, United States

Location

Alcon Investigator 8108

Novato, California, 94945, United States

Location

Alcon Investigator 8062

Oakland, California, 94607, United States

Location

Alcon Investigator 8109

San Francisco, California, 94127, United States

Location

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6355

Orlando, Florida, 32803, United States

Location

Alcon Investigator 8115

Norcross, Georgia, 30071, United States

Location

Alcon Investigator 6567

Pittsburg, Kansas, 66762, United States

Location

Alcon Investigator 8063

Brighton, Massachusetts, 02135, United States

Location

Alcon Investigator 8100

New York, New York, 10036, United States

Location

Alcon Investigator 4817

Cleveland, Ohio, 44106, United States

Location

Alcon Investigator 6313

Powell, Ohio, 43065, United States

Location

Alcon Investigator 6401

Warwick, Rhode Island, 02888, United States

Location

Alcon Investigator 6353

Memphis, Tennessee, 38111, United States

Location

Alcon Investigator 8114

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

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

• Sr. Clinical Trial Lead, CDMA 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: January 22, 2020
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: February 2, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)