Comparison of New Contact Lens With Current Marketed Lens

Study Overview
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Brief Summary
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The purpose of this study is to validate the clinical performance of a new contact lens design.

Detailed Description
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Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Official Title
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Clinical Validation Study of Phoebe Lens

Conditions
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Myopia

Intervention / Treatment
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* Device: Phoebe test lens
* Device: stenfilcon A lens (control)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria A person is eligible for inclusion in the study if he/she: Between and 18 and 35 years of age and has full legal capacity to volunteer Has had a self-reported oculo-visual examination in the last two years Has read and understood the information consent letter Is willing and able to follow instructions and maintain the appointment schedule Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected Has a Contact Lens Refraction between -1.00D and -6.00D Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction Currently wears soft contact lenses Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study Has clear corneas and no active ocular disease Has not worn lenses for at least 12 hours before the first visit Exclusion Criteria A person will be excluded from the study if he/she: Has never worn contact lenses before Is wearing Monovision modality Has any systemic disease affecting ocular health Is using any systemic or topical medications that will affect ocular health Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars Is aphakic 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: 35 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test lens<br>Subjects randomized to wear pair of test lens either first or second | Device: Phoebe test lens<br>* Daily disposable contact lens<br>* Other names: Phoebe Contact Lens;Device: stenfilcon A lens (control)<br>* Daily disposable contact lens<br>* Other names: MyDay daily disposable contact lens;|
| Active Comparator: stenfilcon A lens (control)<br>Subjects randomized to wear pair of control lens either first or second | Device: Phoebe test lens<br>* Daily disposable contact lens<br>* Other names: Phoebe Contact Lens;Device: stenfilcon A lens (control)<br>* Daily disposable contact lens<br>* Other names: MyDay daily disposable contact lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining Extent | Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area). | Baseline | 
| Corneal Staining Extent | Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area). | Day 3 | 
| Conjunctival Staining Score | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps | Baseline | 
| Conjunctival Staining Score | Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps | Day 3 | 
| Palpebral Hyperemia on Upper Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | Baseline | 
| Palpebral Hyperemia on Upper Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | Day 3 | 
| Palpebral Hyperemia on Lower Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | Baseline | 
| Palpebral Hyperemia on Lower Lid | Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps | Day 3 | 
| Palpebral Roughness Grade - Upper Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Baseline | 
| Palpebral Roughness Grade - Upper Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Day 3 | 
| Palpebral Roughness Grade - Lower Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Baseline | 
| Palpebral Roughness Grade - Lower Lid | Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity | Distance visual acuity recorded in logMAR. | Baseline (at lens dispense) | 
| Distance Visual Acuity | Distance visual acuity recorded in logMAR. | Day 3 | 
| Near Visual Acuity | Near visual acuity recorded in logMAR | Baseline (at dispense) | 
| Near Visual Acuity | Near visual acuity recorded in logMAR | Day 3 | 
| Vision Quality Rating | Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent) | Baseline (at dispense) | 
| Vision Quality Rating | Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent) | Day 3 |