Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Study Overview
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Brief Summary
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To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Detailed Description
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This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

Official Title
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Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Conditions
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Myopia

Intervention / Treatment
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* Device: fanfilcon A test lens
* Device: ocufilcon D control lens
* Device: etafilcon A control lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a currently adapted soft contact lens wearer (>1 month of lens wear). Be at least 18 years of age. Refractive astigmatism <1.00D in both eyes. Have clear corneas and be free of any anterior segment disorders. Be correctable through spherocylindrical refraction to 20/25 or better in each eye. Contact lens sphere requirement between -1.00D and -6.00D (inclusive). Require visual correction in both eyes (monovision allowed, no monofit). Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No amblyopia No strabismus No evidence of lid abnormality or infection No conjunctival abnormality or infection that would contraindicate contact lens wear No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities) No other active ocular disease. Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm. Willing to comply with the wear and study visit schedule. Exclusion Criteria: Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics 55. Require toric or multifocal contact lenses. Previously shown a sensitivity to any of the study solution components. Any systemic or ocular disease or allergies affecting ocular health. Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance. Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea. Keratoconus or other corneal irregularity. Aphakia or amblyopia. Have undergone corneal refractive surgery or any anterior segment surgery. Abnormal lacrimal secretions. Has diabetes. Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). History of chronic eye disease (e.g. glaucoma). Pregnant or lactating or planning a pregnancy at the time of enrolment. Participation in any concurrent clinical trial or in last 30 days.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ocufilcon D control lens, then fanfilcon A test lens<br>Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. | Device: fanfilcon A test lens<br>* Silicone hydrogel contact lens<br>* Other names: Avaira Vitality;Device: ocufilcon D control lens<br>* hydrogel contact lens<br>* Other names: ocufilcon D (4-weekly) control lens;|
| Experimental: etafilcon A controls, then fanfilcon A test lens<br>Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. | Device: fanfilcon A test lens<br>* Silicone hydrogel contact lens<br>* Other names: Avaira Vitality;Device: etafilcon A control lens<br>* hydrogel contact lens<br>* Other names: Acuvue 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Comfort Rating | Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses | Two weeks | 
| Subjective Overall Comfort Rating | Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Wearing Time | Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes | Two weeks | 
| Average Wearing Time | Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes | Four weeks | 
| Average Comfortable Wearing Time | Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes. | Two weeks | 
| Average Comfortable Wearing Time | Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes. | Four weeks | 
| Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Baseline (after 15 minutes) | 
| Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Two weeks | 
| Lens Centration | Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)). | Four weeks | 
| Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Baseline (after 15 minutes of lens dispense) | 
| Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Two weeks | 
| Corneal Coverage | Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage) | Four weeks | 
| Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Baseline (after 15 minutes of lens dispense) | 
| Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Two weeks | 
| Post-Blink Movement | Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Four weeks | 
| Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Baseline (after 15 minutes of lens dispense) | 
| Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Two weeks | 
| Lens Tightness - Push-up Test | Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support) | Four weeks | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Baseline (after 15 minutes of lens dispense) | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Two weeks | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect) | Four weeks | 
| Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Baseline (after 15 minutes of lens dispense) | 
| Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Two weeks | 
| Rating of Lens Surface Wettability | Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time). | Four weeks | 
| Presence of Film Deposits | Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye). | Two weeks | 
| Presence of Film Deposits | Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye). | Four weeks | 
| Number of White Spot Deposits | Number of white spot deposits assessed using slit lamp with white light, low medium magnification | Two weeks | 
| Number of White Spot Deposits | Number of white spot deposits assessed using slit lamp with white light, low medium magnification | Four weeks | 
| Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Baseline (after 15 minutes of lens dispense) | 
| Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Two weeks | 
| Primary Gaze Lag | Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement) | Four weeks | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 8:00am | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 12:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 4:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 3 - 8:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 8:00am | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 12:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 4:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 7 - 8:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 8:00am | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 12:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 4:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 12 - 8:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 8:00am | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 12:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 4:00pm | 
| Comfort Throughout the Day | Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses | Day 26 - 8:00pm |