NCT05805059

Brief Summary

The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.

Trial Health

90
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 Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
2 countries

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

March 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 26, 2024

Completed
Last Updated

September 26, 2024

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 28, 2023

Results QC Date

August 13, 2024

Last Update Submit

September 20, 2024

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Lens Handling on Removal

    Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)

    Collected once on day 6 at the end of wear

Study Arms (2)

Control Contact Lens, Then Test Contact Lens

EXPERIMENTAL

Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.

Device: Control Contact Lens (stenfilcon A)Device: Test Contact Lens (senofilcon A)

Test Contact Lens, Then Control Contact Lens

EXPERIMENTAL

Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.

Device: Control Contact Lens (stenfilcon A)Device: Test Contact Lens (senofilcon A)

Interventions

Control Contact Lens (stenfilcon A)DEVICE

one week wear

Control Contact Lens, Then Test Contact LensTest Contact Lens, Then Control Contact Lens
Test Contact Lens (senofilcon A)DEVICE

one week of wear

Control Contact Lens, Then Test Contact LensTest Contact Lens, Then Control Contact Lens

Eligibility Criteria

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

You may qualify if:

  • Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Self-reports having a full eye examination in the previous two years;
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears soft contact lenses, for the past 3 months minimum;
  • No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys
  • No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.
  • Has refractive astigmatism no higher than -0.75DC in each eye;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

You may not qualify if:

  • Is participating in any concurrent clinical or research study;
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery or intraocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Coan Eye Care

Ocoee, Florida, 34761, United States

Location

Sacco Eye Group, PLLC

Vestal, New York, 13850, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Insight Eye Care

Waterloo, Ontario, N2L 3S1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jose A. Vega,OD,MSc,FAAO, PhD
Organization
Coopervision
jvega2@coopervision.com
925-621-3761

Study Officials

  • Andrew Sacco

    Sacco Eye Group, PLLC

    PRINCIPAL INVESTIGATOR

  • Carolyn MacNeil

    Insight Eye Care

    PRINCIPAL INVESTIGATOR

  • Katherine Bickle

    ProCare Vision Center

    PRINCIPAL INVESTIGATOR

  • Roxanne Achong-Coan

    Coan Eye Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
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 28, 2023

First Posted

April 7, 2023

Study Start

April 14, 2023

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

September 26, 2024

Results First Posted

September 26, 2024

Record last verified: 2023-03

Locations

US(3)CA(1)