NCT03586167

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 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 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 13, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

July 2, 2018

Results QC Date

April 22, 2021

Last Update Submit

June 7, 2021

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

  • Distance Visual Acuity (VA)

    VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.

    Day 30

Study Arms (2)

LID014341

EXPERIMENTAL

LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis

Device: LID014341 contact lenses

Biofinity

ACTIVE COMPARATOR

Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis

Device: Comfilcon A contact lenses

Interventions

LID014341 contact lensesDEVICE

Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating

LID014341
Comfilcon A contact lensesDEVICE

Silicone hydrogel contact lenses

Also known as: BIOFINITY©
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 informed consent form approved by an Institutional review board (IRB);
  • Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
  • Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
  • Willing to stop wearing habitual contact lenses for the duration of study participation.

You may not qualify if:

  • Any conditions or use of medications that could contraindicate contact lens wear;
  • History of or plan to have refractive surgery in either eye;
  • Irregular cornea in either eye;
  • Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
  • Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
  • 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;
  • Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
  • Habitual Biofinity contact lens wearers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

Location

Alcon Investigative Site

Bloomington, Illinois, 61701, United States

Location

Alcon Investigative Site

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
CDMA Project Lead
Organization
Alcon Research
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Alcon Research

    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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 13, 2018

Study Start

August 1, 2018

Primary Completion

September 27, 2018

Study Completion

September 27, 2018

Last Updated

June 30, 2021

Results First Posted

May 13, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(4)