Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

Study Overview
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Brief Summary
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Open label, 1-week daily disposable, dispensing study

Detailed Description
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Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

Official Title
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Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* Device: filcon IV 1
* Device: ocufilcon D


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 Avaira sphere contact lens wearer (at least 1 week in Avaira sphere) Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive) Has a spectacle cylinder up to 0.75D in each eye. Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so). Is willing to comply with the visit schedule Exclusion Criteria: Is not a habitual wearer of Avaira sphere lenses Has a CL prescription outside the range of the available parameters of the study lenses. Has a spectacle cylinder ≥1.00D of cylinder in either eye. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GCP) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: filcon IV 1 and ocufilcon D<br>Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses. | Device: filcon IV 1<br>* contact lens<br>Device: ocufilcon D<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit, Centration - Filcon IV 1 and Ocufilcon D | Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable | Baseline and 1 Week | 
| Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D | Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | Baseline and 1 Week | 
| Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D | Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement | Baseline and 1 Week | 
| Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D | Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect. | Baseline and 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity - Filcon IV 1 and Ocufilcon D | Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity). | Baseline and 1 Week | 
| Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel). | Baseline and 1 Week | 
| Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness). | Baseline and 1 Week | 
| Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle). | Baseline and 1 Week | 
| Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied). | Baseline and 1 Week | 
| Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D | Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D. | 1 Week | 
| Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D | Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week | 
| Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D | Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week | 
| Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D | Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week | 
| Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D | Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week | 
| Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D | Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied. | Baseline and 1 Week |