Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Detailed Description
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The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Official Title
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Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: etafilcon A
* Device: stenfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:- Be between 16 and 45 years of age (inclusive) Adapted soft contact lens (CL) wearers (i.e. > 1 month) Spherical distance CL prescription between -1.00 and -6.00D (inclusive) Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other. Correctable to 6/9 (20/30) in both eyes Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. Have read, understood and signed the informed consent Willing to comply with the wear schedule (at least 40 hours per week) Willing to comply with the study visit schedule Exclusion Criteria:- Any active corneal infection, injury or inflammation Systemic or ocular allergies, which might interfere with CL wear Systemic disease, which might interfere with CL wear Ocular disease, which might interfere with CL wear Strabismus, amblyopia Subjects who have undergone corneal refractive surgery and any anterior segment surgery Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear Pregnant or lactating Use of systemic/topical medication contraindicating CL wear Use of gas permeable contact lenses within the last month Employees of the investigational site or immediate family members of Investigators Participation in any concurrent clinical trial or in the last 30 days

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 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 |
| --- | --- |
| Experimental: stenfilcon A<br>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. | Device: etafilcon A<br>* Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.<br>* Other names: etafilcon A (Daily Disposable Contact Lens);|
| Active Comparator: etafilcon A<br>Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. | Device: stenfilcon A<br>* Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.<br>* Other names: stenfilcon A (Daily Disposable Contact Lens);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handling | Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy). | two weeks and four weeks from baseline visit | 
| Satisfaction With Handling | Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | two weeks and four weeks from baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel). | two weeks and four weeks from baseline visit | 
| Dryness | Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness). | two weeks and four weeks from baseline visit | 
| Satisfaction With Dryness | Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | two weeks and four weeks from baseline visit | 
| Satisfaction With Comfort | Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied). | two weeks and four weeks from baseline visit |