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This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A/galyfilcon A | Active Comparator | senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second. |
|
| galyfilcon A/senofilcon A | Active Comparator | galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A toric | Device | silicone hydrogel contact lens for patients with astigmatism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/Galyfilcon A | senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second. |
| FG001 | Galyfilcon A/Senofilcon A | galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Completed Subjects | All subjects that completed the study were analyzed. One subject from the senofilcon A/ galyfilcon A arm dropped from the study between the first and second intervention. The subject moved out of town. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 11 subjects that were high myopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
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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 | Senofilcon A | senofilcon A silicone hydrogel toric contact lenses worn in the first or second intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asymptomatic infiltrative event | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch OD | Vistakon | 904-443-1707 |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| galyfilcon A toric | Device | silicone hydrogel contact lens for patients with astigmatism |
|
|
Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
| after 6 hours of wear |
| Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | after 6 hours of wear |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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This group represents all high myope subjects that completed the study and wore galyfilcon A toric contact lenses as first or second intervention.
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|
| Primary | Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 14 subjects that were hyperopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
|
| Primary | Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 13 subjects that were oblique astigmats within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
|
| Primary | Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 11 subjects that were high myopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
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| Primary | Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 14 subjects that were hyperopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
|
| Primary | Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 13 subjects that were oblique astigmats within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
|
|
|
| Primary | Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 11 subjects that were high myopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
|
|
|
| Primary | Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 14 subjects that were hyperopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
|
|
|
| Primary | Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 13 subjects that were oblique astigmats within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
|
| Primary | Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 11 subjects that were high myopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
|
| Primary | Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 14 subjects that were hyperopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
|
| Primary | Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 13 subjects that were oblique astigmats within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
|
|
|
| Primary | Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 11 subjects that were high myopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
|
|
|
| Primary | Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 14 subjects that were hyperopes within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
|
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|
| Primary | Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea) | Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe. | There were 13 subjects that were oblique astigmats within the total completed population of 38. | Posted | Least Squares Mean | Standard Error | Units on a scale | after 6 hours of wear |
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| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | Galyfilcon A | galyfilcon A silicone hydrogel toric contact lenses worn in the first or second intervention. | 0 | 20 | 2 | 20 |
| non-significant corneal infiltrate event | Eye disorders | Non-systematic Assessment |
|
The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.