Evaluation of Stenfilcon A Versus Etafilcon A

Evaluation of two contact lenses

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Stenfilcon A; Device: Etafilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Etafilcon A; Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously	Device: Stenfilcon A
EXPERIMENTAL: Stenfilcon A; Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously	Device: Etafilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Insertion, After Lens 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	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	Dispense
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	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	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	12-hours, 1-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Insertion, 12 hours, 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	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.	Insertion
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.	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	Baseline, 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	Baseline, 12-hours, 1-week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, PhD., FCO, Univeristy of Waterloo, Canada

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (ESTIMATE): March 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-12-57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No