NCT03095027

Brief Summary

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

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

March 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 4, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

26 days

First QC Date

March 23, 2017

Results QC Date

January 8, 2019

Last Update Submit

January 8, 2019

Conditions

Refractive Error

Keywords

contact lens, silicone hydrogel, daily disposable, visual acuity

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity (VA)

    VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

    Baseline/Dispense (Day 1), Week 1, each product

Study Arms (2)

FID122819, then stenfilcon A

OTHER

FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week

Device: FID122819 contact lensesDevice: Stenfilcon A contact lenses

Stenfilcon A, then FID122819

OTHER

Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week

Device: FID122819 contact lensesDevice: Stenfilcon A contact lenses

Interventions

FID122819 contact lensesDEVICE

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Also known as: DDT2, Verofilcon A
FID122819, then stenfilcon AStenfilcon A, then FID122819
Stenfilcon A contact lensesDEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Also known as: MyDay®
FID122819, then stenfilcon AStenfilcon A, then FID122819

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-approved Informed Consent Form;
  • Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
  • Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
  • Best corrected visual acuity (BCVA) of 20/25 or better in each eye;

You may not qualify if:

  • Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
  • Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
  • History of refractive surgery or plan to have refractive surgery during the study;
  • Ocular or intraocular surgery within the previous 12 months or planned during the study;
  • Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
  • Any previous or current wear of MYDAY;
  • Habitually wearing monovision or multifocal lenses during the last 3 months;
  • Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
  • Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alcon Investigative Site

Longwood, Florida, 32779, United States

Location

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

Study Officials

  • Sr. Clinical Manager, Trial Management Operations

    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
Masking Details
Alcon Observer and Sponsor personnel were also masked.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 29, 2017

Study Start

April 19, 2017

Primary Completion

May 15, 2017

Study Completion

May 15, 2017

Last Updated

February 4, 2019

Results First Posted

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)