NCT03459131

Brief Summary

The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 2, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

19 days

First QC Date

March 2, 2018

Results QC Date

February 13, 2019

Last Update Submit

February 13, 2019

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

  • Subjective Rating of Overall Vision

    Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.

    Day 7, each product

Secondary Outcomes (1)

  • Over-refraction

    Day 1 (Dispense), each product

Study Arms (2)

BIOFINITY ENERGYS then BIOFINITY

OTHER

Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.

Device: Comfilcon A with Digital Zone Optics™ contact lensesDevice: Comfilcon A contact lenses

BIOFINITY then BIOFINITY ENERGYS

OTHER

Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.

Device: Comfilcon A with Digital Zone Optics™ contact lensesDevice: Comfilcon A contact lenses

Interventions

Comfilcon A with Digital Zone Optics™ contact lensesDEVICE

Silicone hydrogel spherical contact lenses with Digital Zone Optics™

Also known as: BIOFINITY® ENERGYS™
BIOFINITY ENERGYS then BIOFINITYBIOFINITY then BIOFINITY ENERGYS
Comfilcon A contact lensesDEVICE

Silicone hydrogel spherical contact lenses

Also known as: BIOFINITY®
BIOFINITY ENERGYS then BIOFINITYBIOFINITY then BIOFINITY ENERGYS

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Able to understand and sign an approved informed consent form (ICF);
  • Successful wear of BIOFINITY® (spherical) (or private label) 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;
  • Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
  • Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;

You may not qualify if:

  • Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
  • Refractive, ocular, or intraocular surgery, as specified in the protocol;
  • Current or history of eye injury or disorders, as specified in the protocol;
  • Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
  • Habitual contact lens wear 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 that would require instillation during contact lens wear;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Sr Clinical Project Lead, GCRA - Vision Care
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Alcon, A Novartis Division

    Alcon, A Novartis Division

    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

March 2, 2018

First Posted

March 8, 2018

Study Start

March 7, 2018

Primary Completion

March 26, 2018

Study Completion

March 26, 2018

Last Updated

March 5, 2019

Results First Posted

March 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)