NCT05725317

Brief Summary

The purpose of this study is to assess the overall clinical performance of a contact lens made with a modified manufacturing process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 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

February 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 2, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

July 1, 2024

Enrollment Period

25 days

First QC Date

February 3, 2023

Results QC Date

June 24, 2024

Last Update Submit

July 15, 2024

Conditions

Refractive ErrorsMyopia

Outcome Measures

Primary Outcomes (1)

  • Least Squares Mean Distance Visual Acuity (VA) With Study Lenses at Day 4

    VA was assessed for each eye individually at a distance of 4 meters with contact lenses in place using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

    Day 4

Study Arms (2)

LID220365 (OD) / LID006961 (OS)

OTHER

LID220365 contact lens worn in the right eye (OD), with LID006961 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.

Device: LID220365 contact lensDevice: LID006961 contact lens

LID006961 (OD) / LID220365 (OS)

OTHER

LID006961 contact lens worn in the right eye (OD), with LID220365 contact lens worn in the left eye (OS), as randomized, for four days. A fresh pair of lenses will be worn each day.

Device: LID220365 contact lensDevice: LID006961 contact lens

Interventions

LID220365 contact lensDEVICE

Investigational delefilcon A spherical contact lens made with a modified manufacturing process

LID006961 (OD) / LID220365 (OS)LID220365 (OD) / LID006961 (OS)
LID006961 contact lensDEVICE

Commercially available delefilcon A spherical contact lens

Also known as: DAILIES TOTAL1®
LID006961 (OD) / LID220365 (OS)LID220365 (OD) / LID006961 (OS)

Eligibility Criteria

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

You may qualify if:

  • Successful wearer of spherical soft contact lenses of the same brand in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
  • Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
  • Best corrected visual acuity (BCVA) better than or equal to 0.10 logMAR in each eye.

You may not qualify if:

  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during study participation.
  • 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.
  • Habitual monovision or multifocal contact lens wearers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kindred Optics at Maitland Vision

Maitland, Florida, 32751, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Franklin Park Eye Center PC

Franklin Park, Illinois, 60131, United States

Location

SUNY College of Optometry Clinical Vision Research Center

New York, New York, 10036, United States

Location

Wyomissing Optometric Center

Wyomissing, Pennsylvania, 19610, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

Clarke Eyecare Center

Wichita Falls, Texas, 76308, United States

Location

MeSH Terms

Conditions

Refractive ErrorsMyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Sr. Clinical Project Lead, 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 13, 2023

Study Start

June 2, 2023

Primary Completion

June 27, 2023

Study Completion

June 27, 2023

Last Updated

August 6, 2024

Results First Posted

August 6, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(7)