Clinical Evaluation of Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single-Center Clinical Evaluation of Daily Disposable Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: filcon II 3
* Device: etafilcon A
* Device: nelfilcon A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: etafilcon A lens<br>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. | Device: etafilcon A<br>* Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.<br>* Other names: Hydrogel Daily Disposable Contact Lens;|
| Active Comparator: nelfilcon A lens<br>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. | Device: nelfilcon A<br>* Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.<br>* Other names: Hydrogel Daily Disposable Contact Lens;|
| Active Comparator: filcon II 3 lens<br>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. | Device: filcon II 3<br>* Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.<br>* Other names: Silicone Hydrogel Daily Disposable Contact Lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Preference - All Study Lenses | 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). | Study Exit | 
| Overall Lens Preference - Hydrogel vs. Filcon II 3 | 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). | Study Exit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Response for Comfort | 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) | Baseline and 3 day follow-up | 
| Subjective Response for Vision | 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). | Baseline and 3 day follow-up | 
| Subjective Response for Insertion | Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle). | Baseline | 
| Subjective Response for Handling (Insertion and Removal) | 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). | 3 days follow-up | 
| Subjective Response for Dryness | 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). | 3 Days Follow-up | 
| Overall Satisfaction, Vision | 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. | 3 Days Follow-up | 
| Overall Satisfaction, Comfort | 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. | 3 Days Follow-up | 
| Overall Satisfaction, Handling | 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. | 3 Days | 
| Overall Satisfaction, Dryness | 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. | 3 Days Follow-up | 
| Overall Satisfaction | 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. | 3 Days Follow-up | 
| Lens Fit and Performance - Wettability (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). | Baseline and 3 days follow-up | 
| Lens Fit and Performance - Deposits (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); | Baseline and 3 days follow-up | 
| Lens Fit and Performance - Debris (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) | Baseline and 3 day follow-up | 
| Lens Fit and Performance - Movement (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). | Baseline and 3 days follow-up | 
| Lens Fit and Performance - Fit Acceptance | 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). | Baseline and 3 day follow-up | 
| Lens Fit and Performance - Tightness (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). | Baseline and 3 day follow-up | 
| Ocular Health - Biomicroscopy | 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) | 3 Days Follow-up |