NCT04476784

Brief Summary

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

July 15, 2020

Results QC Date

September 29, 2021

Last Update Submit

September 29, 2021

Conditions

Myopia

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (1)

  • Mean Distance Visual Acuity (logMAR) With Study Lenses

    Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

    Day 1, Day 30 after 6-8 hours of wear, each product

Study Arms (2)

LID018869, then Biofinity

OTHER

Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.

Device: Lehfilcon A contact lensesDevice: Comfilcon A contact lensesDevice: CLEAR CARE

Biofinity, then LID018869

OTHER

Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.

Device: Lehfilcon A contact lensesDevice: Comfilcon A contact lensesDevice: CLEAR CARE

Interventions

Lehfilcon A contact lensesDEVICE

Investigational silicone hydrogel contact lenses

Also known as: LID018869
Biofinity, then LID018869LID018869, then Biofinity
Comfilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses

Also known as: CooperVision® BIOFINITY®, Biofinity
Biofinity, then LID018869LID018869, then Biofinity
CLEAR CAREDEVICE

Hydrogen peroxide-based cleaning and disinfecting solution

Biofinity, then LID018869LID018869, then Biofinity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;
  • Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;

You may not qualify if:

  • Current or prior Biofinity contact lens wearer in the past 3 months;
  • Monovision contact lens wearer;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site

Bloomington, Illinois, 61704, United States

Location

Alcon Investigative Site

Pittsburg, Kansas, 66762, United States

Location

Alcon Investigative Site

Shawnee Mission, Kansas, 66204, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye 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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

August 17, 2020

Primary Completion

November 18, 2020

Study Completion

November 18, 2020

Last Updated

October 26, 2021

Results First Posted

October 26, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(5)