NCT04403542

Brief Summary

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 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

May 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 3, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
3 years until next milestone

Results Posted

Study results publicly available

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

28 days

First QC Date

May 21, 2020

Results QC Date

July 27, 2023

Last Update Submit

August 18, 2023

Conditions

Refractive ErrorsMyopiaHyperopia

Keywords

Extended WearContact LensOvernight WearVision CorrectionContralateral Wear

Outcome Measures

Primary Outcomes (1)

  • Distance Visual Acuity (VA) With Study Lenses

    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 a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

    Day 1 Dispense; Day 2 Follow-up (within 4 hours of awakening); Week 1 Follow-up/Exit

Study Arms (2)

LID018869 (OD) / Biofinity (OS)

EXPERIMENTAL

Lehfilcon A contact lens worn in the right eye, with comfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear

Device: Lehfilcon A contact lensDevice: Comfilcon A contact lens

Biofinity (OD) / LID018869 (OS)

ACTIVE COMPARATOR

Comfilcon A contact lens worn in the right eye, with lehfilcon A contact lens worn in the left eye, as randomized, for approximately 1 week of continuous wear

Device: Lehfilcon A contact lensDevice: Comfilcon A contact lens

Interventions

Lehfilcon A contact lensDEVICE

Investigational silicone hydrogel contact lens

Also known as: LID018869
Biofinity (OD) / LID018869 (OS)LID018869 (OD) / Biofinity (OS)
Comfilcon A contact lensDEVICE

Commercially available silicone hydrogel contact lens

Also known as: Biofinity
Biofinity (OD) / LID018869 (OS)LID018869 (OD) / Biofinity (OS)

Eligibility Criteria

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

You may qualify if:

  • Able to understand and sign an IRB/IEC approved Informed Consent form.
  • Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
  • Best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

  • Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
  • Any habitual wear of Biofinity contact lenses.
  • Pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alcon Investigator 6402

Medina, Minnesota, 55340, United States

Location

Alcon Investigator 8046

Granville, Ohio, 43023, United States

Location

Alcon Investigator 2786

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Refractive ErrorsMyopiaHyperopia

Condition Hierarchy (Ancestors)

Eye 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

  • CDMA Project 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
Model Details: In this contralateral study, subjects will be randomized to wear the investigational lens in 1 eye and the control lens in the other eye.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 27, 2020

Study Start

August 3, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

August 22, 2023

Results First Posted

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)