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A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
comfilcon A Extended Range test lens
comfilcon A control lens
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Presbyopia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • 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

Exclusion Criteria:

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.

Sites / Locations

  • CORL, Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

comfilcon A Extended Range test lens

comfilcon A control lens

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective Ratings for Comfort
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Subjective Ratings for Comfort
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Subjective Ratings for Dryness
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Subjective Ratings for Dryness
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Lens Handling
Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).
Average Daily Wearing Time
Average daily wearing time for test and control lens is assessed in hours.
Lens Fit
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.
Bulbar Hyperemia
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Limbal Hyperemia
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Subjective Satisfaction
Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
Subjective Preference for Near Vision
Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.
Subjective Preference for Distance Vision
Subjective preference for distance vision for test and control contact lenses.
Subjective Preference for Intermediate Vision
Subjective preference for intermediate vision for test and control contact lenses.
Subjective Preference for Overall Vision
Subjective preference for overall vision for test and control contact lenses.
Subjective Preference for Comfort
Subjective preference for comfort for test and control contact lenses.
Subjective Overall Lens Preference
Subjective overall lens preference for test and control contact lenses.

Full Information

First Posted
March 21, 2016
Last Updated
July 20, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02719353
Brief Title
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Official Title
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comfilcon A Extended Range test lens
Arm Type
Experimental
Arm Description
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
Arm Title
comfilcon A control lens
Arm Type
Active Comparator
Arm Description
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair.
Intervention Type
Device
Intervention Name(s)
comfilcon A Extended Range test lens
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
comfilcon A control lens
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR.
Time Frame
4 days
Title
Visual Performance
Description
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).
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Subjective Ratings for Comfort
Description
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time Frame
Baseline
Title
Subjective Ratings for Comfort
Description
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time Frame
4 days
Title
Subjective Ratings for Dryness
Description
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Time Frame
Baseline
Title
Subjective Ratings for Dryness
Description
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time).
Time Frame
4 days
Title
Lens Handling
Description
Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle).
Time Frame
4 Days
Title
Average Daily Wearing Time
Description
Average daily wearing time for test and control lens is assessed in hours.
Time Frame
4 days
Title
Lens Fit
Description
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit.
Time Frame
4 days
Title
Bulbar Hyperemia
Description
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Time Frame
4 days
Title
Limbal Hyperemia
Description
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Time Frame
4 days
Title
Subjective Satisfaction
Description
Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied)
Time Frame
4 days
Title
Subjective Preference for Near Vision
Description
Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction.
Time Frame
4 days
Title
Subjective Preference for Distance Vision
Description
Subjective preference for distance vision for test and control contact lenses.
Time Frame
4 days
Title
Subjective Preference for Intermediate Vision
Description
Subjective preference for intermediate vision for test and control contact lenses.
Time Frame
4 days
Title
Subjective Preference for Overall Vision
Description
Subjective preference for overall vision for test and control contact lenses.
Time Frame
4 days
Title
Subjective Preference for Comfort
Description
Subjective preference for comfort for test and control contact lenses.
Time Frame
4 days
Title
Subjective Overall Lens Preference
Description
Subjective overall lens preference for test and control contact lenses.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A person is eligible for inclusion in the study if he/she: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pete S Kollbaum, O.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CORL, Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

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