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Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stenfilcon A lens with solution additive (test)
stenfilcon A lens (control)
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 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 at least 18 years of age and has full legal capacity to volunteer.
    • Has read and understood the information consent letter.
    • Is willing and able to follow instructions and maintain the appointment schedule.
    • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
    • Must achieve 20/30 or better (in each eye) with study lenses
    • Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
    • Has no more than 0.75 diopters of refractive astigmatism.
    • Currently wears soft contact lenses.
    • Have clear corneas and no active ocular disease.
    • Has not worn lenses for at least 12 hours before the examination

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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
    • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
    • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
    • Is aphakic.
    • Has undergone corneal refractive surgery.
    • Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
    • Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Sites / Locations

  • Clinical Optical Research Lab (CORL)
  • The Ocular Surface Institute (TOSI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stenfilcon A lens with solution additive (test)

stenfilcon A lens (control)

Arm Description

Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.

Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.

Outcomes

Primary Outcome Measures

Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Overall Corneal Staining
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Overall Corneal Staining
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Conjunctival Staining
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Conjunctival Staining
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Bulbar Hyperemia
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Bulbar Hyperemia
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Limbal Hyperemia
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Limbal Hyperemia
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Palpebral Hyperemia
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Palpebral Hyperemia
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

Secondary Outcome Measures

Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Handling Satisfaction
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Handling Satisfaction
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry

Full Information

First Posted
January 17, 2017
Last Updated
July 8, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03024970
Brief Title
Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
Official Title
Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
June 26, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).
Detailed Description
This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months. Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
stenfilcon A lens with solution additive (test)
Arm Type
Experimental
Arm Description
Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
Arm Title
stenfilcon A lens (control)
Arm Type
Active Comparator
Arm Description
Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.
Intervention Type
Device
Intervention Name(s)
stenfilcon A lens with solution additive (test)
Intervention Description
silicone hydrogel lens
Intervention Type
Device
Intervention Name(s)
stenfilcon A lens (control)
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Subjective Ratings on Comfort
Description
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time Frame
Baseline
Title
Subjective Ratings on Comfort
Description
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time Frame
1 Week
Title
Subjective Ratings on Comfort
Description
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time Frame
1 Month
Title
Vision Satisfaction
Description
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time Frame
Baseline
Title
Vision Satisfaction
Description
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time Frame
1 week
Title
Vision Satisfaction
Description
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time Frame
1 Month
Title
Visual Acuity On High Illumination High Contrast
Description
Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame
Baseline
Title
Visual Acuity On High Illumination High Contrast
Description
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame
1 Week
Title
Visual Acuity On High Illumination High Contrast
Description
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame
1 Month
Title
Visual Acuity On Low Illumination High Contrast
Description
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame
Baseline
Title
Visual Acuity On Low Illumination High Contrast
Description
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame
1 Week
Title
Visual Acuity On Low Illumination High Contrast
Description
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time Frame
1 Month
Title
Overall Corneal Staining
Description
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Time Frame
One Week
Title
Overall Corneal Staining
Description
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Time Frame
One Month
Title
Conjunctival Staining
Description
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Time Frame
1 Week
Title
Conjunctival Staining
Description
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Time Frame
1 Month
Title
Bulbar Hyperemia
Description
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame
1 Week
Title
Bulbar Hyperemia
Description
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame
1 Month
Title
Limbal Hyperemia
Description
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame
1 Week
Title
Limbal Hyperemia
Description
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame
1 Month
Title
Palpebral Hyperemia
Description
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame
1 Week
Title
Palpebral Hyperemia
Description
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Lens Fit Acceptance
Description
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame
Baseline
Title
Lens Fit Acceptance
Description
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame
1 week
Title
Lens Fit Acceptance
Description
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time Frame
1 Month
Title
Handling Satisfaction
Description
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Time Frame
1 week
Title
Handling Satisfaction
Description
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Time Frame
1 Month
Title
Lens Surface - Wettability
Description
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time Frame
Baseline
Title
Lens Surface - Wettability
Description
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time Frame
1 Week
Title
Lens Surface - Wettability
Description
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time Frame
1 Month
Title
Lens Surface - Deposits
Description
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time Frame
Baseline
Title
Lens Surface - Deposits
Description
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time Frame
1 week
Title
Lens Surface - Deposits
Description
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time Frame
1 Month
Title
Subjective Ratings on Dryness
Description
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time Frame
Baseline
Title
Subjective Ratings on Dryness
Description
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time Frame
1 week
Title
Subjective Ratings on Dryness
Description
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 at least 18 years of age and has full legal capacity to volunteer. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. Must achieve 20/30 or better (in each eye) with study lenses Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps). Has no more than 0.75 diopters of refractive astigmatism. Currently wears soft contact lenses. Have clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination 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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Is aphakic. Has undergone corneal refractive surgery. Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit). Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pete Kollbaum, OD, PhD
Organizational Affiliation
Clinical Optics Research Lab (CORL) Indiana University School of Optometry.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Ritchey, OD, PhD, FAAO
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Optical Research Lab (CORL)
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
The Ocular Surface Institute (TOSI)
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

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