NCT05579886

Brief Summary

The objective of the study was to adapt existing multifocal soft lens wearers to a Control Lens for at least 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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

Study Start

First participant enrolled

October 10, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

October 11, 2022

Results QC Date

January 25, 2024

Last Update Submit

January 25, 2024

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Comfort Just After Lens Insertion

    Subjective rating measured on a scale of 0-10, 0.5 steps, where 0=Painful, 10=Can't feel the lenses.

    2 weeks

Study Arms (2)

Control Lens

ACTIVE COMPARATOR

All participants wore the Control Lens for 2 weeks (Period 1)

Device: Control Lens

Test Lens

EXPERIMENTAL

All participants wore the Test Lens for 2 weeks (Period 2)

Device: Test Lens

Interventions

Control LensDEVICE

Daily disposable multifocal soft lens with 2 add design (2ADD) for 2 weeks

Control Lens
Test LensDEVICE

Daily disposable multifocal soft lens with 3 add design (3ADD) for 2 weeks

Test Lens

Eligibility Criteria

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

You may qualify if:

  • Was at least 42 years of age and had full legal capacity to volunteer;
  • Had read and signed an information consent letter;
  • Self-reported having had a full eye examination in the previous two years;
  • Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week;
  • Was willing and able to follow instructions and maintain the appointment schedule;
  • Habitually wore multifocal soft contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens type was restricted such that no more than one third were to be the clariti 1 day multifocal and no more than one third were to be MyDay multifocal (this included their equivalent private label brand name);
  • Had refractive astigmatism no higher than -0.75DC in each eye;
  • Was presbyopic and required a reading addition of at least +0.75D and no more than +2.50D in each eye;
  • Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)

You may not qualify if:

  • A person was excluded from the study if he/she:
  • Was participating in any concurrent clinical or research study;
  • Had any known active ocular disease and/or infection that contraindicated contact lens wear;
  • Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
  • Was using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
  • Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
  • Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Had undergone refractive error surgery or interocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Coan Eye Care & Optical Boutique

Ocoee, Florida, 34761, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Nittany Eye Associates

State College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
José A. Vega OD, MSc, FAAO, PhD
Organization
CooperVision Inc.
javega@coopervision.com
19256213761

Study Officials

  • Andrew Sacco

    Sacco Eye Group

    PRINCIPAL INVESTIGATOR

  • Shane Kannarr

    Kannarr Eye Care

    PRINCIPAL INVESTIGATOR

  • Katherine Bickle

    ProCare Vision Center

    PRINCIPAL INVESTIGATOR

  • Michael Cymbor

    Nittany Eye Associates

    PRINCIPAL INVESTIGATOR

  • Roxanne Achong-Coan

    Coan Eye Care & Optical Boutique

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

October 10, 2022

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

February 20, 2024

Results First Posted

February 20, 2024

Record last verified: 2024-01

Locations

US(5)