NCT05010512

Brief Summary

The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 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

August 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 8, 2022

Completed
Last Updated

November 8, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

August 11, 2021

Results QC Date

October 11, 2022

Last Update Submit

October 11, 2022

Conditions

Refractive ErrorsAmetropiaMyopia

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 8 (-0/+3), each study lens type

Study Arms (2)

DT1, then Infuse

OTHER

Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.

Device: Delefilcon A contact lensesDevice: Kalifilcon A contact lenses

Infuse, then DT1

OTHER

Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.

Device: Delefilcon A contact lensesDevice: Kalifilcon A contact lenses

Interventions

Delefilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Also known as: DAILIES TOTAL1®, DT1
DT1, then InfuseInfuse, then DT1
Kalifilcon A contact lensesDEVICE

Commercially available silicone hydrogel contact lenses used as indicated

Also known as: Bausch + Lomb INFUSE™, Infuse
DT1, then InfuseInfuse, then DT1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
  • At least 3 months of contact lens wearing experience;
  • Less than or equal to 0.75 diopter (D) astigmatism in each eye;
  • Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.

You may not qualify if:

  • Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
  • Monovision and/or multifocal lens wearer;
  • Routinely sleeps in habitual contact lenses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Alcon Investigator 6355

Orlando, Florida, 32803, United States

Location

Alcon Investigator 6418

Tallahassee, Florida, 32308, United States

Location

Alcon Investigator 3950

Bloomington, Illinois, 61704, United States

Location

Alcon Investigator 6614

Franklin Park, Illinois, 60131, United States

Location

Alcon Investigator 6583

Eden Prairie, Minnesota, 55344, United States

Location

Alcon Investigator 3382

Wyomissing, Pennsylvania, 19610, United States

Location

Alcon Investigator 6353

Memphis, Tennessee, 38111, United States

Location

Alcon Investigator 2786

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Refractive ErrorsMyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Associate Director, Clinical Projects - CDMA 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

August 11, 2021

First Posted

August 18, 2021

Study Start

August 31, 2021

Primary Completion

October 12, 2021

Study Completion

October 12, 2021

Last Updated

November 8, 2022

Results First Posted

November 8, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(8)