Clinical Evaluation of Daily Disposable Contact Lenses

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: nelfilcon A
Device: etafilcon A
Device: filcon II 3

Registration Number: NCT02097030

Lead Sponsor: Coopervision, Inc.

Brief Summary: The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.

Detailed Description: Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

Inclusion Criteria

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft CL wearer
Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
Has less than 1.25 D spectacle cylinder in each eye.
Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter
Is willing to comply with the wear schedule (at least 3 full days)
Is willing to comply with the visit schedule

Exclusion Criteria

Has never worn contact lenses before.
Currently wears rigid gas permeable contact lenses.
Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)
Has a CL prescription outside the range of - 1.00 to -6.00D
Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
Has best corrected spectacle distance vision worse then 20/25 in either eye.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
Has any ocular pathology or severe insufficiency of lacrimal secretion
Has persistent, clinically significant corneal or conjunctival staining
Has active neovascularization or any central corneal scars.
Is aphakic.
Is presbyopic.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nelfilcon A lens	nelfilcon A	Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
etafilcon A lens	etafilcon A	Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.
filcon II 3 lens	filcon II 3	Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.

Primary Outcome Measures

Name	Time	Method
Overall Lens Preference - Hydrogel vs. Filcon II 3	Study Exit	Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Overall Lens Preference - All Study Lenses	Study Exit	Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).

Secondary Outcome Measures

Name	Time	Method
Subjective Response for Insertion	Baseline	Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Subjective Response for Vision	Baseline and 3 day follow-up	Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).
Overall Satisfaction, Handling	3 Days	Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Overall Satisfaction	3 Days Follow-up	Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Overall Satisfaction, Comfort	3 Days Follow-up	Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Subjective Response for Comfort	Baseline and 3 day follow-up	Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)
Overall Satisfaction, Vision	3 Days Follow-up	Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)	Baseline and 3 days follow-up	The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).
Subjective Response for Handling (Insertion and Removal)	3 days follow-up	Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Subjective Response for Dryness	3 Days Follow-up	Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)	Baseline and 3 day follow-up	The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)	Baseline and 3 day follow-up	The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Overall Satisfaction, Dryness	3 Days Follow-up	Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)	Baseline and 3 days follow-up	The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)	Baseline and 3 days follow-up	The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).
Ocular Health - Biomicroscopy	3 Days Follow-up	The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)
Lens Fit and Performance - Fit Acceptance	Baseline and 3 day follow-up	The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).