NCT03762668

Brief Summary

The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

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

December 1, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 7, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

December 1, 2018

Results QC Date

December 19, 2019

Last Update Submit

January 9, 2020

Conditions

Refractive ErrorsMyopiaHyperopia

Keywords

Contact lensVision correctionVisual acuity

Outcome Measures

Primary Outcomes (1)

  • High Contrast Distance Visual Acuity (logMAR)

    Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.

    Day 1 Dispense, Day 7 Follow-Up

Study Arms (2)

MDACL, then DACL

OTHER

Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.

Device: Modified delefilcon A contact lensesDevice: Delefilcon A contact lenses

DACL, then MDACL

OTHER

DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.

Device: Modified delefilcon A contact lensesDevice: Delefilcon A contact lenses

Interventions

Modified delefilcon A contact lensesDEVICE

Spherical soft daily disposable contact lens

Also known as: MDACL
DACL, then MDACLMDACL, then DACL
Delefilcon A contact lensesDEVICE

Spherical soft daily disposable contact lens

Also known as: DACL
DACL, then MDACLMDACL, then DACL

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;
  • Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;

You may not qualify if:

  • Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
  • Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;
  • Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)
  • Monocular (only one eye with functional vision);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site

Orlando, Florida, 32803, United States

Location

Alcon Investigative Site

West Palm Beach, Florida, 33405, United States

Location

Alcon Investigative Site

Ann Arbor, Michigan, 48105, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive ErrorsMyopiaHyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Sr. CDMA Project Lead, Vision Care
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr. CDMA Project Lead, Vision Care

    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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2018

First Posted

December 4, 2018

Study Start

December 3, 2018

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

January 13, 2020

Results First Posted

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)