NCT02719353

Brief Summary

The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

July 21, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

March 21, 2016

Results QC Date

July 2, 2020

Last Update Submit

July 20, 2020

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (2)

  • Visual Acuity

    Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.

    4 days

  • Visual Performance

    Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).

    4 days

Secondary Outcomes (16)

  • Subjective Ratings for Comfort

    Baseline

  • Subjective Ratings for Comfort

    4 days

  • Subjective Ratings for Dryness

    Baseline

  • Subjective Ratings for Dryness

    4 days

  • Lens Handling

    4 Days

  • +11 more secondary outcomes

Study Arms (2)

comfilcon A Extended Range test lens

EXPERIMENTAL

Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.

Device: comfilcon A Extended Range test lensDevice: comfilcon A control lens

comfilcon A control lens

ACTIVE COMPARATOR

Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.

Device: comfilcon A Extended Range test lensDevice: comfilcon A control lens

Interventions

comfilcon A Extended Range test lensDEVICE

contact lens

comfilcon A Extended Range test lenscomfilcon A control lens
comfilcon A control lensDEVICE

contact lens

comfilcon A Extended Range test lenscomfilcon A control lens

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has had a self-reported oculo-visual examination in the last two years
  • Is 50 years of age or greater and has full legal capacity to volunteer
  • Is able to read and understand the informed consent
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
  • Near Add Power requirement of +2.25D or greater
  • Has spectacle cylinder 0.75 D in both eyes
  • Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
  • Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
  • Has clear corneas and no active ocular disease
  • Has not worn gas permeable contact lenses for 1 month prior to the study

You may not qualify if:

  • A person will be excluded from the study if he/she:
  • Has never worn contact lenses before
  • Has any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has any ocular pathology or abnormality that would affect the wearing of contact lenses
  • Is aphakic (i.e. missing their natural lens inside their eye)
  • Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
  • Has undergone corneal refractive surgery
  • Is participating in any other type of eye related clinical or research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CORL, Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Myhanh Nguyen
Organization
CooperVision, Inc.
mnguyen@coopervision.com
925-730-6716

Study Officials

  • Pete S Kollbaum, O.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

July 30, 2020

Results First Posted

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)