Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

NCT04085328 | Completed Results FDA Device

• 1 other identifier: CLL949-C010
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 42

Brief Summary

The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

Conditions

Refractive Ametropia

Outcome Measures

Primary Outcomes (3)

• Distance Visual Acuity (VA) With Study Lenses - Completed Eyes

  Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.

  Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up

• Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes

  Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters 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. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.

  Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up

• Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)

  Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).

  Up to Month 12

Study Arms (2)

LID015385

EXPERIMENTAL

LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.

Device: LID015385 soft contact lenses

Biofinity

ACTIVE COMPARATOR

Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol.

Device: Comfilcon A soft contact lenses

Interventions

LID015385 soft contact lenses DEVICE

Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear

LID015385

Comfilcon A soft contact lenses DEVICE

Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear

Also known as: BIOFINITY®

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 Informed Consent Form.
• Willing to attend all scheduled study visits as required per protocol.
• Willing and able to wear assigned study lenses as required per protocol.
• Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
• Manifest cylinder ≤ 0.75 diopter (D) in each eye.

You may not qualify if:

• Any eye infection, inflammation, or 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 eye surgery, including refractive surgery.
• Currently pregnant or breast-feeding.
• Monovision contact lens wearers.
• Daily disposable contact lens wearers.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (42)

Family EyeCare Center

Campbell, California, 95008, United States

Location

Winston Eye Care

Fullerton, California, 92835, United States

Location

Kurata Eye Care Center

Los Angeles, California, 90012, United States

Location

East West Eye Institute

Los Angeles, California, 90013, United States

Location

Dr.Elsa Pao, O.D

Oakland, California, 94607, United States

Location

Gordon Schanzlin New Vision Institute

San Diego, California, 92122, United States

Location

Complete Family Vision Care

San Diego, California, 92123, United States

Location

Westview Optometry

San Diego, California, 92129, United States

Location

OMEGA Vision Center PA, DBA Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Kindred Optics at Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Mid Florida Eye Center, PA

Mt. Dora, Florida, 32757, United States

Location

Eola Eyes

Orlando, Florida, 32803, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Visual Performance Center Research & Development

Pensacola, Florida, 32503, United States

Location

Golden Vision

Sarasota, Florida, 34237, United States

Location

Advanced Eyecare Specialists

West Palm Beach, Florida, 33405, United States

Location

VisionPoint Eye Center

Bloomington, Illinois, 61704, United States

Location

Franklin Park Eye Center, PC

Franklin Park, Illinois, 60131, United States

Location

Kannarr Eye Care, LLC

Pittsburg, Kansas, 66762, United States

Location

Optimum Vision Care

Brighton, Massachusetts, 02135, United States

Location

Fraser Eye Care Center

Fraser, Michigan, 48026, United States

Location

Dr. Schwartz Optometrist and Associates

Sterling Heights, Michigan, 48312, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Fischer Laser Eye Center, LLC

Willmar, Minnesota, 56201, United States

Location

Tekwnai Vision Center, Inc

St Louis, Missouri, 63128, United States

Location

Alterman, Modi & Wolter

Poughkeepsie, New York, 12603, United States

Location

Rochester Ophthalmological Group, PC

Rochester, New York, 14618, United States

Location

Asheville Eye Associates, PLLC

Asheville, North Carolina, 28803, United States

Location

ProCare Vision Centers, Inc.

Granville, Ohio, 43023, United States

Location

Midwest Vision Care

Piqua, Ohio, 45356, United States

Location

EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC

Powell, Ohio, 43065, United States

Location

Wyomissing Optometric Center

Wyomissing, Pennsylvania, 19610, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

North Spartanburg Eye Center

Boiling Springs, South Carolina, 29316, United States

Location

Primary Eyecare Group, PC

Brentwood, Tennessee, 37027, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research, LLC

Smyrna, Tennessee, 37167, United States

Location

Beaumont Family Eye Care

Beaumont, Texas, 77706, United States

Location

Vision One Eyecare

Katy, Texas, 77450, United States

Location

Dawn M Rakich, OD

San Antonio, Texas, 78213, United States

Location

Clarke EyeCare Center

Wichita Falls, Texas, 76308, United States

Location

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon Study Director

  Alcon Research

  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: September 9, 2019
• First Posted: September 11, 2019
• Study Start: October 11, 2019
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (42)