NCT03349632

Brief Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 22, 2019

Completed
Last Updated

February 22, 2019

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

November 17, 2017

Results QC Date

January 30, 2019

Last Update Submit

January 30, 2019

Conditions

Refractive Error

Keywords

Contact lensesMyopiaNear-sightedDaily disposable

Outcome Measures

Primary Outcomes (1)

  • Overall Quality of Vision

    Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.

    Day 8, each product

Study Arms (3)

DD T2/Oasys 1-Day

OTHER

Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized

Device: verofilcon A contact lensesDevice: senofilcon A contact lenses

DD T2/MyDay

OTHER

Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Device: verofilcon A contact lensesDevice: stenfilcon A contact lenses

DD T2/Moist

OTHER

Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Device: verofilcon A contact lensesDevice: etafilcon A contact lenses

Interventions

verofilcon A contact lensesDEVICE

Investigational spherical silicone hydrogel contact lenses for daily disposable wear

Also known as: DDT2
DD T2/MoistDD T2/MyDayDD T2/Oasys 1-Day
senofilcon A contact lensesDEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Also known as: ACUVUE OASYS® 1-Day with HydraLuxe™ Technology, Oasys 1-Day
DD T2/Oasys 1-Day
stenfilcon A contact lensesDEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Also known as: MyDay®, MyDay
DD T2/MyDay
etafilcon A contact lensesDEVICE

Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Also known as: 1-Day ACUVUE® MOIST, Moist
DD T2/Moist

Eligibility Criteria

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

You may qualify if:

  • Able to understand and must sign an approved Informed Consent Form
  • Successfully wears daily disposable 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
  • Best Corrected Visual Acuity of 20/25 Snellen or better in each eye
  • Willing to stop wearing habitual contact lenses for the duration of study participation

You may not qualify if:

  • Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
  • Routinely sleeps in habitual contact lenses
  • Currently wears Oasys 1-Day, MyDay, or Moist contact lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alcon Investigative Site

Maitland, Florida, 32751, United States

Location

Alcon Investigative Site

Pensacola, Florida, 32503, United States

Location

Alcon Investigative Site

Johns Creek, Georgia, 30097, United States

Location

MeSH Terms

Conditions

Refractive ErrorsMyopia

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

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

November 17, 2017

First Posted

November 21, 2017

Study Start

January 10, 2018

Primary Completion

February 16, 2018

Study Completion

February 16, 2018

Last Updated

February 22, 2019

Results First Posted

February 22, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)