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Evaluation of Stenfilcon A Versus Etafilcon A

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Etafilcon A
Stenfilcon A
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
  • Has astigmatism less than or equal to -1.00D;
  • Is an adapted soft contact lens wearer;
  • Demonstrates an acceptable fit with the study lenses;
  • Has no active anterior segment disease or known ocular disease.

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, neovascularization, corneal scars or corneal opacities;
  • Is aphakic;
  • Has undergone corneal refractive surgery;
  • Is participating in any other type of clinical or research study;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Sites / Locations

  • Center for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Etafilcon A

Stenfilcon A

Arm Description

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Outcomes

Primary Outcome Measures

Participant's Subjective Rating of Comfort (Questionnaire)
Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week
Participant's Subjective Rating of Dryness (Questionnaire)
Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Visual Quality (Questionnaire)
Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week
Participant's Subjective Rating of Overall Preference (Questionnaire)
Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week

Secondary Outcome Measures

Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week).
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week

Full Information

First Posted
January 17, 2013
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01809834
Brief Title
Evaluation of Stenfilcon A Versus Etafilcon A
Official Title
Evaluation of Stenfilcon A Versus Etafilcon A
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
November 2013 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of two contact lenses
Detailed Description
One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etafilcon A
Arm Type
Active Comparator
Arm Description
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Arm Title
Stenfilcon A
Arm Type
Experimental
Arm Description
Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Intervention Type
Device
Intervention Name(s)
Etafilcon A
Intervention Type
Device
Intervention Name(s)
Stenfilcon A
Primary Outcome Measure Information:
Title
Participant's Subjective Rating of Comfort (Questionnaire)
Description
Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week
Time Frame
Insertion, After Lens settling, 12-hours, 1-week
Title
Participant's Subjective Rating of Dryness (Questionnaire)
Description
Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week
Time Frame
12-hours, 1-week
Title
Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
Description
Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing
Time Frame
Dispense
Title
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
Description
Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week
Time Frame
12-hours, 1-week
Title
Participant's Subjective Rating of Visual Quality (Questionnaire)
Description
Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week
Time Frame
12-hours, 1-week
Title
Participant's Subjective Rating of Overall Preference (Questionnaire)
Description
Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week
Time Frame
12-hours, 1-week
Secondary Outcome Measure Information:
Title
Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
Description
Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week).
Time Frame
Insertion, 12 hours, 1 week
Title
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
Description
Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week
Time Frame
Insertion, 12 hours, 1 week
Title
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
Description
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Time Frame
Insertion
Title
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
Description
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Time Frame
Insertion, 12-hours, 1-week
Title
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
Description
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Time Frame
Baseline, 12-hours, 1-week
Title
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
Description
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Time Frame
Baseline, 12-hours, 1-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is at least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses; Has astigmatism less than or equal to -1.00D; Is an adapted soft contact lens wearer; Demonstrates an acceptable fit with the study lenses; Has no active anterior segment disease or known ocular disease. 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, neovascularization, corneal scars or corneal opacities; Is aphakic; Has undergone corneal refractive surgery; Is participating in any other type of clinical or research study; Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD., FCO
Organizational Affiliation
Univeristy of Waterloo, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

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Evaluation of Stenfilcon A Versus Etafilcon A

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