NCT04952701

Brief Summary

The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 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

June 28, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 26, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

June 28, 2021

Results QC Date

March 29, 2022

Last Update Submit

April 25, 2022

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Comfort on Insertion

    Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).

    Day 1 after Lens Dispense Visit

Study Arms (2)

Control Lens

ACTIVE COMPARATOR

All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks.

Device: Control lensesDevice: Test lenses

Test Lens

EXPERIMENTAL

After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks.

Device: Control lensesDevice: Test lenses

Interventions

Control lensesDEVICE

Control Multifocal lenses

Control LensTest Lens
Test lensesDEVICE

Test Multifocal lenses

Control LensTest Lens

Eligibility Criteria

Age42 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is at least 42 years of age 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, 5 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
  • Has refractive astigmatism no higher than -0.75DC;
  • Is presbyopic and requires a reading addition of at least +0.75D and no more than
  • +2.50D;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

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 (5)

Coan EyeCare

Ocoee, Florida, 34761, United States

Location

Kannarr Eye care

Pittsburg, Kansas, 66762, United States

Location

Sacco Eye Group PLLC

Vestal, New York, 13850, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Nittany Eye Associates

College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jose Vega
Organization
CooperVision
JVega2@coopervision.com
9256402964

Study Officials

  • Lyndon Jones

    University of Waterloo

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 7, 2021

Study Start

October 21, 2021

Primary Completion

December 1, 2021

Study Completion

January 14, 2022

Last Updated

April 27, 2022

Results First Posted

April 26, 2022

Record last verified: 2022-04

Locations

US(5)