Evaluation of Stenfilcon A Versus Etafilcon A

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Etafilcon A
Device: Stenfilcon A

Registration Number: NCT01809834

Lead Sponsor: Coopervision, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stenfilcon A	Etafilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A	Stenfilcon A	Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Primary Outcome Measures

Name	Time	Method
Participant's Subjective Rating of Dryness (Questionnaire)	12-hours, 1-week	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)	Dispense	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 Overall Preference (Questionnaire)	12-hours, 1-week	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
Participant's Subjective Rating of Comfort (Questionnaire)	Insertion, After Lens settling, 12-hours, 1-week	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 Visual Quality (Questionnaire)	12-hours, 1-week	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 Lens Handling for Removal (Questionnaire)	12-hours, 1-week	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

Secondary Outcome Measures

Name	Time	Method
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)	Insertion, 12 hours, 1 week	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 Lens Surface Wettability (Biomicroscopy)	Insertion, 12 hours, 1 week	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 Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)	Baseline, 12-hours, 1-week	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
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)	Insertion, 12-hours, 1-week	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 Visual Acuity, High Contrast at High Illumination (Snellen)	Insertion	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 Anterior Ocular Physiological Response, Cornea (Biomicroscopy)	Baseline, 12-hours, 1-week	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