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This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.
Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A asphere (test) | Experimental | Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). |
|
| comfilcon A sphere (control) | Active Comparator | Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A sphere lens (control) | Device | contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Centration | Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable). | baseline, 2 weeks, 1 month |
| Lens Fit - Corneal Coverage | Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage). | baseline, 2 weeks, 1 month |
| Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | baseline, 2 weeks, 1 month |
| Lens Preference/Acceptability | Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses). | baseline, 2 weeks, 1 month |
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Inclusion criteria
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria
A person will be excluded from the study if he/she:
Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
Presents with clinically significant anterior segment abnormalities
Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
Presents with slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Is habitually using rewetting/ lubricating eye drops (more than once per day)
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Sacco, OD | Sacco Eye Group | Principal Investigator |
| Gina Wesley, OD | Complete Eye Care of Medina | Principal Investigator |
| Thomas Quinn, OD, MS, FAAO | Drs. Quinn, Foster, & Associates | Principal Investigator |
| David Ardaya, OD | Golden Optometric Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Complete Eye Care of Medina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) | Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| comfilcon A asphere lens (test) |
| Device |
contact lens |
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| Medina |
| Minnesota |
| 55340 |
| United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Drs. Quinn, Foster, & Associates | Athens | Ohio | 45701 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) | Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Lens Fit - Centration | Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable). | One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation. | Posted | Number | participants | baseline, 2 weeks, 1 month |
|
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| Primary | Lens Fit - Corneal Coverage | Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage). | One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation. | Posted | Number | participants | baseline, 2 weeks, 1 month |
|
| ||||||||||||||||||||||||||||||
| Primary | Lens Fit - Post-blink Movement | Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement). | One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation. | Posted | Mean | Standard Deviation | units on a scale | baseline, 2 weeks, 1 month |
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| Primary | Lens Preference/Acceptability | Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses). | Posted | Number | participants | baseline, 2 weeks, 1 month |
|
|
4 weeks
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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 | Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test) | Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens | 0 | 52 | 0 | 52 |
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There is an agreement between the Principal Investigator and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Medical Scientific Affairs | CooperVision | 1-925-621-3761 | javega@coopervision.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Baseline, Acceptable |
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| Baseline, Unacceptable |
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| At 2 weeks, optimum |
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| At 2 weeks, acceptable |
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| At 2 weeks, unacceptable |
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| At 1 month, optimum |
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| At 1 month, acceptable |
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| At 1 month, unacceptable |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Strongly prefer comfilcon A asphere |
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| Slightly prefer comfilcon A asphere |
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| Strongly prefer comfilcon A sphere |
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| Slightly prefer comfilcon A sphere |
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