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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,
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,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sapphire | Experimental | Subjects randomized to the experimental contact lens over the study duration |
|
| Pearl | Active Comparator | Subjects randomized to the active comparator contact lens over the study duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sapphire | Device | silicone hydrogel contact lens |
| |
| Pearl |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L Saltzman, MD, FACOG | Sterling IRB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric M White OD, Inc. | San Diego | California | 92123 | United States | ||
| Office of Mark E Nakano, O.D. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sapphire | Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens |
| FG001 | Pearl | Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sapphire | Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens |
| BG001 | Pearl |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
From Dispense up to one month on study lenses
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sapphire | Subjects were randomized in a 2:1(Test: Control) ratio to the experimental contact lens over the study duration Sapphire: silicone hydrogel contact lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pappilary Conjuctivitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision, Inc. | 925-730-6716 | mnguyen@coopervision.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Device |
silicone hydrogel contact lens |
|
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 |
| Torrance |
| California |
| 90503 |
| United States |
| Advanced Family Eye Care | Denver | North Carolina | 28037 | United States |
| Quinn Foster & Associates | Athens | Ohio | 45701 | United States |
| Primary Eyecare Group, P.C. | Brentwood | Tennessee | 37027 | United States |
| Premier Vision Services, LLC | Amarillo | Texas | 79119 | United States |
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration
Pearl: silicone hydrogel contact lens
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens |
|
|
| Primary | 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) | Data for two test eyes and two control eyes were not collected. | Posted | Number | Eyes | 1 Month | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | 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) | Data for two test eyes and two control eyes were not collected | Posted | Number | Eyes | 1 month | Eyes | Eyes |
|
|
|
| Primary | Slit Lamp Findings for Corneal Infiltrates | Slit Lamp Findings for Corneal Infiltrates - Present, Absent | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | Slit Lamp Findings for Corneal Infiltrates | Slit Lamp Findings for Corneal Infiltrates - Present, Absent | Data for two test lens and two control lens were not collected | Posted | Number | Eyes | 1 Month | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | 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) | Data for two test eyes and two control eyes were not collected | Posted | Number | Eyes | 1 month | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | 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) | Data for two test eyes and two control eyes were not collected. | Posted | Number | Eyes | 1 month | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | 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) | Data for two test eyes and two control eyes were not collected. | Posted | Number | Eyes | 1 month | Eyes | Eyes |
|
|
|
| Primary | Slit Lamp Findings for Palpebral Conjunctiva | Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | Slit Lamp Findings for Palpebral Conjunctiva | Slit Lamp Findings for Palpebral Conjunctiva - Present, Absent | Data for two test eyes and two control eyes were not collected | Posted | Number | Eyes | 1 month | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Number | Eyes | Baseline (After lens dispensing) | Eyes | Eyes |
|
|
|
| Primary | 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) | Data for two test eyes and two control eyes were not collected | Posted | Number | Eyes | 1 month | Eyes | Eyes |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 7 |
| 59 |
| EG001 | Pearl | Subjects were randomized in a 2: 1 ratio (Test: Control) to the active comparator contact lens over the study duration Pearl: silicone hydrogel contact lens | 0 | 30 | 0 | 30 | 2 | 30 |
| Corneal Infiltrate | Eye disorders | Systematic Assessment |
|
| Foreign body Abrasion | Eye disorders | Systematic Assessment |
|
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 4 |
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| Grade 3 |
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| Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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| Grade 2 |
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| Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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