Evaluation of Silicone Hydrogel Daily Wear Contact Lenses for Up to One (1) Month of Daily Wear

Study Overview
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Brief Summary
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The aim of the study is to evaluate if the performance of Invigor A is substantially equivalent to Invigor B contact lenses when used in a one month recommended replacement, daily wear modality.

Detailed Description
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This study is a multi-centered, daily wear, monthly replacement, bilateral, randomized in a ratio of two to one (2:1) Test to Control, lens blocked (subjects remain in the same lens brand throughout the study), licensed investigator and subject masked, concurrent controlled study with a study duration of approximately three months evaluating performance equivalence of Invigor A (test) over Invigor B (control) contact lenses.

Official Title
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Evaluation of the CooperVision, Inc. Invigor A and Invigor B 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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Myopia, Hyperopia, Astigmatism

Intervention / Treatment
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* Device: Invigor A (test)
* Device: Invigor B (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age as of the date of evaluation for the study Have Read the informed consent document Been given an explanation of the informed consent document indicated understanding of the informed consent document Signed the informed consent document Be willing and able to adhere to the instructions provided by the investigational site and be willing to keep all specified appointments. Be an adapted, frequent replacement, 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. Exclusion Criteria: 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(s) or of the investigational office staff. A known sensitivity to the ingredients used in the multi-purpose solution approved for use in the study and is unable or unwilling to use the alternate care system. Had previous refractive surgery; or current or previous orthokeratology treatment. Aphakic or pseudophakic. 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. 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.

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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Accepts Healthy Volunteers

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: Invigor A (test)<br>Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study. | Device: Invigor A (test)<br>* silicone hydrogel lens<br>|
| Active Comparator: Invigor B (Control)<br>Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study. | Device: Invigor B (control)<br>* silicone hydrogel lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Epithelial Edema - Slit Lamp Findings | Epithelial edema on slit lamp grading scale 0 - 4 (0- 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 | 
| Number of Eyes With Epithelial Edema - Slit Lamp Findings | Epithelial edema on slit lamp grading scale 0 - 4 (0- 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) | One Month | 
| Number of Eyes With Stromal Edema - Slit Lamp Findings | Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae | Baseline | 
| Number of Eyes With Stromal Edema - Slit Lamp Findings | Stromal edema on slit lamp grading scale 0-4 (0 None - No edema, 1 Trace - Just detectable clouding, 2 Mild - faint corneal striae, 3 Moderate - Pronounced corneal striae, 4 severe - folds in Descemet's membrane and ≥4 pronounced striae | One Month | 
| Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Corneal Vascularization on slit lamp grading scale 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) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior | Baseline | 
| Number of Eyes With Corneal Vascularization - Slit Lamp Findings | Corneal Vascularization on slit lamp grading scale 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) Depth: a. - Epithelial b. - Anterior Stromal c. - Mid/Posterior Stromal Location: N - Nasal T - Temporal I - Inferior S - Superior | One Month | 
| Number of Eyes With Corneal Staining - Slit Lamp Findings | Corneal Staining with fluorescent on slit lamp findings - Present / Absent | Baseline | 
| Number of Eyes With Corneal Staining - Slit Lamp Findings | Corneal Staining with fluorescent on slit lamp findings - Present / Absent | One Month | 
| Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Corneal Infiltrates on slit lamp findings - Present / Absent | Baseline | 
| Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent | One Month | 
| Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal). | Baseline | 
| Number of Eyes With Limbal Hyperemia - Slit Lamp Findings | Limbal Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight limbal hyperemia (mild segmented), 2 Mild: Mild limbal hyperemia (mild circumcorneal), 3 Moderate: Significant limbal hyperemia (marked segmented), 4 Severe: Severe limbal hyperemia (marked circumcorneal). | One Month | 
| Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia) | Baseline | 
| Number of Eyes With Bulbar Hyperemia - Slit Lamp Findings | Bulbar Hyperemia on slit lamp grading scale 0-4 (0 None: No hyperemia, 1 Trace: Slight regional hyperemia, 2 Mild: Diffuse hyperemia, 3 Moderate: Marked regional or diffuse hyperemia, 4 Severe: Diffuse episcleral or scleral hyperemia) | One Month | 
| Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings | Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent | Baseline | 
| Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings | Palpebral Conjunctival Observations on slit lamp findings - Present / Absent | One Month | 
| Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings | Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe) | Baseline | 
| Number of Eyes With Other Findings - Conjunctival Infection, Epidemic Keratoconjunctivitis, Corneal Ulcers, Iritis, Lens Adhesions and Recurrent Erosion - Slit Lamp Findings | Clinical entities such as conjunctival infection, epidemic keratoconjunctivitis, corneal ulcers, iritis, lens adhesions and recurrent erosion on Slit lamp grading scale of 0-4 (0 None 1 Trace, 2 Mild, 3 Moderate, 4 Severe) | One Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Visual Acuity for an Effective Visual Distance of 20 Feet | Number of Eyes With Visual Acuity was assessed using Snellen VA Chart for an effective visual distance of 20 feet | One Month |