Evaluation of Investigational (Frequent Replacement) FRP Lens for Daily Wear

Study Overview
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Brief Summary
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The purpose of the study is to compare the investigational contact lens to a marketed contact lens. The study results were not used for design validation of investigational contact lens,

Detailed Description
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The objective of this evaluation is to provide evidence supporting the claim that the performance of the Test Lens is substantially equivalent to that of the Control Lens when used in a one month (up to 30 days) recommended replacement, daily wear modality. The study results were not used for design validation of investigational contact lens,

Official Title
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Evaluation of the CooperVision, Inc. Sapphire and Pearl Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear.

Conditions
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Ametropia

Intervention / Treatment
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* Device: Sapphire
* Device: Pearl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior to being considered eligible to participate in this study, each subject MUST: Be at least 18 years of age as of the date of evaluation for the study. Have: Read the Informed Consent been given an explanation of the Informed Consent indicated understanding of the Informed Consent signed the Informed Consent document. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments. Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study. Possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses. Be in good general health, based on his/her knowledge. Require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes. Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye. To be eligible for lens dispensing, the subject must achieve 20/30 VA or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal. Exclusion Criteria: Subjects may not be enrolled in this study if any of the following apply: The subject is currently or has: Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis. Poor personal hygiene. Any active participation in another clinical trial during this trial or within 30 days prior to this study. To the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months. A member, relative or household member of the investigator or of the investigational office staff. Has a known sensitivity to the ingredients used in the MPS approved for use in the study and is unable or unwilling to use the alternate care system. Previous refractive surgery; or current or previous orthokeratology treatment. Is aphakic or psuedophakic. Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes. The need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day. The presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures. A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections. A history of papillary conjunctivitis that has interfered with contact lens wear. Slit lamp findings that would contraindicate contact lens wear, including but not limited to: Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2 Pterygium Corneal scars within the visual axis Neovascularization or ghost vessels > 1.0 mm in from the limbus Giant papillary conjunctivitis (GPC) of > Grade 2 Anterior uveitis or iritis Seborrheic eczema, seborrheic conjunctivitis or blepharitis

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sapphire<br>Subjects randomized to the experimental contact lens over the study duration | Device: Sapphire<br>* silicone hydrogel contact lens<br>|
| Active Comparator: Pearl<br>Subjects randomized to the active comparator contact lens over the study duration | Device: Pearl<br>* silicone hydrogel contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings for Epithelial Edema | Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: No microcysts; normal transparency, 1 TRACE: 1 to 20 microcysts; barely discernible local epithelial haziness, 2 MILD: 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 MODERATE: 51 to 100 microcysts; significant localized or generalized haziness, 4 SEVERE: >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae) | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Epithelial Edema | Slit Lamp Findings for Epithelial Edema on a grade of 0-4 (0 NONE: No microcysts; normal transparency, 1 TRACE: 1 to 20 microcysts; barely discernible local epithelial haziness, 2 MILD: 21 to 50 microcysts; faint but definite localized or generalized haziness, 3 MODERATE: 51 to 100 microcysts; significant localized or generalized haziness, 4 SEVERE: >100 microcysts; definite widespread epithelial cloudiness giving a dull glass appearance to the cornea, or numerous coalescing bullae) | 1 Month | 
| Slit Lamp Findings for Stromal Edema | Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae) | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Stromal Edema | Slit Lamp Findings for Stromal Edema on a grade of 0-4 (0 NONE: No edema, 1 TRACE: Just detectable clouding, 2 MILD: Faint corneal striae (2 or fewer), 3 MODERATE: Pronounced corneal striae (3), 4 SEVERE: Folds in Descemet's membrane and >4 pronounced striae) | 1 month | 
| Slit Lamp Findings for Corneal Infiltrates | Slit Lamp Findings for Corneal Infiltrates - Present, Absent | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Corneal Infiltrates | Slit Lamp Findings for Corneal Infiltrates - Present, Absent | 1 Month | 
| Slit Lamp Findings for Corneal Vascularization | Slit Lamp Findings for Corneal Vascularization on a grade 0-4 (0 NONE: No vessel penetration, 1 TRACE: <1.00 mm vessel penetration, 2 MILD: >1.00 mm to <1.50 mm vessel penetration, 3 MODERATE: >1.50 mm to <2.00 mm vessel penetration, 4 SEVERE: Vessel penetration >2.00 mm) | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Corneal Vascularization | Slit Lamp Findings for Corneal Vascularization on a grade 0-4 (0 NONE: No vessel penetration, 1 TRACE: <1.00 mm vessel penetration, 2 MILD: >1.00 mm to <1.50 mm vessel penetration, 3 MODERATE: >1.50 mm to <2.00 mm vessel penetration, 4 SEVERE: Vessel penetration >2.00 mm) | 1 month | 
| Slit Lamp Findings for Limbal Hyperemia | Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia) | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Limbal Hyperemia | Slit Lamp Findings for Limbal Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia) | 1 month | 
| Slit Lamp Findings for Bulbar Hyperemia | Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia) | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Bulbar Hyperemia | Slit Lamp Findings for Bulbar Hyperemia on a grade 0-4 (0 NONE: No hyperemia present, 1 TRACE: Slight regional hyperemia, 2 MILD: Diffuse hyperemia, 3 MODERATE: Marked regional or diffuse hyperemia, 4 SEVERE: Diffuse episcleral or scleral hyperemia) | 1 month | 
| Slit Lamp Findings for Palpebral Conjunctiva | Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Palpebral Conjunctiva | Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent | 1 month | 
| Slit Lamp Findings for Other Findings | Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE) | Baseline (After lens dispensing) | 
| Slit Lamp Findings for Other Findings | Slit Lamp Findings for Other findings (conjunctival infection, corneal ulcers, iritis, lens adhesions and recurrent erosion) on a grade 0-4 (0 NONE, 1 TRACE, 2 MILD, 3 MODERATE, 4 SEVERE) | 1 month |