NCT05166902

Brief Summary

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

December 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

December 8, 2021

Results QC Date

June 30, 2023

Last Update Submit

July 24, 2023

Conditions

Ametropia

Outcome Measures

Primary Outcomes (1)

  • Subjective Ratings on Lens Handling on Removal

    Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)

    Day 27

Study Arms (2)

Lens A, Then Lens B

EXPERIMENTAL

Participants will wear lens A for one month and then cross over to wear lens B for one month.

Device: Lens A (comfilcon A lens)Device: Lens B (lehfilcon A lens)

Lens B, Then Lens A

EXPERIMENTAL

Participants will wear lens B for one month and then cross over to wear lens A for one month.

Device: Lens A (comfilcon A lens)Device: Lens B (lehfilcon A lens)

Interventions

Lens A (comfilcon A lens)DEVICE

1 month

Lens A, Then Lens BLens B, Then Lens A
Lens B (lehfilcon A lens)DEVICE

1 month

Lens A, Then Lens BLens B, Then Lens A

Eligibility Criteria

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

You may qualify if:

  • Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Self-reports having a full eye examination in the previous two years;
  • Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
  • Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
  • Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: The habitual contact lens brand was restricted such that no more than one third were to be Biofinity Energys brand (or their equivalent private label brand name) and no more than one third were to be Alcon brand);
  • 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 +6.00 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 or ocular 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

Nittany Eye Associate

State College, Pennsylvania, 168801, United States

Location

Eyes on Sheppard Clinic

Toronto, Ontario, M2N 3A4, Canada

Location

Spadina Optometry

Toronto, Ontario, M5V 3E7, Canada

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Jose A Vega, OD, MSc, FAAO
Organization
CooperVision
javega2@coopervision.com
9256213761

Study Officials

  • David Wilkinson

    Spadina Optometry

    PRINCIPAL INVESTIGATOR

  • Roxanne Achong-Coan

    Coan Eyecare

    PRINCIPAL INVESTIGATOR

  • Fiona Soong

    Eyes on Sheppard Clinic

    PRINCIPAL INVESTIGATOR

  • Mike Cymbor

    Nittany Eye Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 8, 2021

First Posted

December 22, 2021

Study Start

January 31, 2022

Primary Completion

July 9, 2022

Study Completion

July 9, 2022

Last Updated

July 27, 2023

Results First Posted

July 27, 2023

Record last verified: 2022-05

Locations

US(2)CA(2)