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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invigor A (test) | Experimental | Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study. |
|
| Invigor B (Control) | Active Comparator | Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invigor A (test) | Device | silicone hydrogel lens |
| |
| Invigor B (control) |
| 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 |
| 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 |
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Inclusion Criteria:
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 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:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Quinn, O.D | Quinn, Foster & Associates, OH | Principal Investigator |
| Peter Van Hoven, O.D | Primary Eyecare group, P.C, TN | Principal Investigator |
| Mark Nakano, O.D | Mark Nakano, O.D, CA | Principal Investigator |
| David Ziegler, O.D | Ziegler Leffingwell Eye Center, WI | Principal Investigator |
| Cheryl Vincent Riemer, O.D | Vision Care Associates, MI | Principal Investigator |
| Carmen Castellano, O.D | The Koetting Associates, MO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mark Nakano. O.D | Torrance | California | 90503 | United States | ||
| Vision Care Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Invigor A (Test) | Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens |
| FG001 | Invigor B (Control) | Subjects will be randomized in a ratio of two to one (2:1) Test to Control, to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Invigor A (Test) | Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens |
| BG001 | Invigor B (Control) |
| 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 | 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) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
From dispense up to one month for each 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 | Invigor A (Test) | Subjects will be randomized to wear Invigor A (test) for one month of daily wear during the study. Invigor A (test): silicone hydrogel lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martine Robie | CooperVision, Inc. | 9256604477 | mrobie@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2018 | Jul 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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The subject will know the name of the lens however they will not be aware of which lens is investigational and which lens has been previously cleared. The licensed investigator has not been informed which lens is the investigational lens.
| Device |
silicone hydrogel lens |
|
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 |
| East Lansing |
| Michigan |
| 48823 |
| United States |
| The Koetting Associates | St Louis | Missouri | 63144 | United States |
| Quinn, Foster & Associates | Athens | Ohio | 45701 | United States |
| Primary Eyecare Group, P.C | Brentwood | Tennessee | 37027-7552 | United States |
| Ziegler Leffingwell Eye Center | West Allis | Wisconsin | 53227 | United States |
| Protocol Violation |
|
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor A (test) and Invigor B (control) for one month of daily wear during the study. Invigor B (Control): silicone hydrogel 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 |
|
| Invigor B (Control) |
Subjects will be randomized in a ratio of two to one (2:1) Test to Control to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens |
|
|
| Primary | 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) | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | 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 | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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 | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | 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 | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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 | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | Number of Eyes With Corneal Staining - Slit Lamp Findings | Corneal Staining with fluorescent on slit lamp findings - Present / Absent | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | Number of Eyes With Corneal Staining - Slit Lamp Findings | Corneal Staining with fluorescent on slit lamp findings - Present / Absent | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Corneal Infiltrates on slit lamp findings - Present / Absent | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | Number of Eyes With Corneal Infiltrates - Slit Lamp Findings | Number of Eyes With Corneal Infiltrates on slit lamp findings - Present / Absent | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | 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). | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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). | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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) | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | Number of Eyes With Palpebral Conjunctival Observations - Slit Lamp Findings | Number of Eyes With Palpebral Conjunctival Observations on slit lamp findings - Present / Absent | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | Number of Eyes With Palpebral Conjunctiva - Slit Lamp Findings | Palpebral Conjunctival Observations on slit lamp findings - Present / Absent | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Primary | 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) | Posted | Number | Eyes | Baseline | Eyes | Eyes |
|
|
|
| Primary | 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) | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| Secondary | 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 | Two eyes data was not collected for both test and control lens at the one month visit due to lens discomfort. | Posted | Number | Eyes | One Month | Eyes | Eyes |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Invigor B (Control) | Subjects will be randomized to wear Invigor B (Control) for one month of daily wear during the study. Invigor B (control): silicone hydrogel lens | 0 | 28 | 0 | 28 | 0 | 28 |
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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 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 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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| 20/25 |
|